Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338702
Status:
WITHDRAWN
Last Update Posted:
2023-08-28
First Post:
2006-06-16
Brief Title:
A Randomized Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Industry support and funding not forthcoming
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Foot ulcers represent a significant common complication in patients with diabetes Wound healing is a challenge Some wounds do not respond to the best practices in wound care Considerable effort has been directed at therapies to improve the rate of healing
There are a variety of growth factors which have been used to stimulate wound healing Human platelets are an autologous source of growth factors which probably can stimulate healing Autologous platelet gel APG is prepared by centrifugation of autologous human whole blood APG is rich in platelet growth factors This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers
This study will compare the use of autologous platelet gel study group and standard care control group in the treatment of diabetic plantar forefoot ulcers This study will also compare the cost and quality of life in the two groups
Objectives of the study
To determine if topical APG autologous platelet gel is beneficial in the treatment of diabetic foot ulcers
To determine if it will result in a faster rate of wound healing
To determine if it will improve the quality of life in patients with diabetic foot ulcers
There are a variety of growth factors which have been used to stimulate wound healing Human platelets are an autologous source of growth factors which probably can stimulate healing Autologous platelet gel APG is prepared by centrifugation of autologous human whole blood APG is rich in platelet growth factors This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers
This study will compare the use of autologous platelet gel study group and standard care control group in the treatment of diabetic plantar forefoot ulcers This study will also compare the cost and quality of life in the two groups
Objectives of the study
To determine if topical APG autologous platelet gel is beneficial in the treatment of diabetic foot ulcers
To determine if it will result in a faster rate of wound healing
To determine if it will improve the quality of life in patients with diabetic foot ulcers
Detailed Description:
Study Design This will be a single center randomized controlled prospective study comparing the use of autologous platelet gel study group and traditional moist dressing control group in the treatment of plantar forefoot ulcers
Specific Aims Primary - Facilitation of healing of diabetic foot ulcers Secondary - Reduction in amputations and average total cost of care Determine the impact of diabetic ulcers on patients quality of life Research Background Foot ulcers represent a significant common complication in patients with diabetes It is estimated that twenty percent of all patients with diabetes develop a foot ulcer which may subsequently lead to below knee amputation 85 of them preceded by non-healing foot ulcers
Health care costs associated with diabetic foot wound management are staggering Armstrong et al 1998 reported that wound care for foot ulcer patients over a two year period had mean cost of 2700000 US In Toronto the average cost of below knee amputations including hospitalization and rehabilitation is 4000000
Wound healing in the context of diabetes is a challenge for both the health care provider and the patient In a systematic review conducted by Margolis et al 1999 wound healing outcomes using best practices have yielded only 24 at 12 weeks 31 in 20 weeks
Falanga Sabolinski 2001 identified that initial wound size reduction of 01 cmweek is highly predictive of wound closure whereas initial healing rates 006 cm or less predict non-healing Similarly 51 percent reduction in 4 weeks was found to be a good predictor of achieving wound closure Margolis et al 1999 Some wounds do not respond and considerable effort has been directed at therapies to improve the rate of healing in this situation
A variety of growth factors which have been used to stimulate wound healing Human platelets are an autologous source which probably can stimulate healing Autologous platelet gel APG is a material presently utilized as a tissue adhesive It is derived from platelet rich plasma PRP that was first developed in the early 1990s to primarily address acute surgical hemostatic and wound healing problems
APG is prepared by centrifugation of autologous human whole blood which initially separates it into three components packed red cells platelet poor plasma and platelet rich plasma PRP PRP has two to eight times the normal concentration of platelets in human blood The key element that differentiates APG from traditional fibrin glue is the presence of concentrated platelets rich in platelet growth factors These important elements of the blood in an increased concentration are potentially helpful in improving the rate of wound healing This study will investigate the potential improvement in wound healing with APG in diabetic foot ulcers
Rationale for the Research
To determine if topical APG autologous platelet gel is beneficial in the treatment of diabetic foot ulcers
To determine if it will result in a faster rate of wound healing
To determine if it will improve the quality of life in patients with diabetic foot ulcers Study Population Subjects for this study will be recruited from our patient population Fifty patients will be randomized to one of the two treatment groups 9 study and control
Inclusion Criteria
1 18 years of age
2 Type I or Type II Diabetes
3 Plantar forefoot ulcers beneath metatarsal head or toe ulcer which has been present for at least 4 weeks and has received best practice care
4 Evidence of adequate arterial perfusion Toe plethysmography reading of 45 mmHg or Transcutaneous oxygen measurement of 30mmHg
5 Patient is appropriately offloaded contact cast pneumatic walking cast
6 Infection andor osteomyelitis have been ruled out or are being treated
7 Platelet count greater than150000mm3
8 Orthopedic assessment has been completed to rule out mechanical source of ulceration
9 Patients with following skeletal deformities could be included -
1 Tendoachillis contracture - after tendoachillis contracture lengthening has been done
2 Charcot arthropathy with concurrent surgical intervention
3 Toe deformities hallus valgus significant claw toe deformities withafter surgical intervention
4 Major axial malalignment hindfoot varusvalgas pes planus pes cavus withafter surgical intervention
10 Patients taking clopidogrel Plavix and aspirin could be included in the study Patients taking aspirin for non medical reason will be asked to discontinue the medicine one week before the start of treatment
Exclusion Criteria
1 TcPO2 30 mmHg andor toe plethysmography readings of less than 45 mmHg
2 Limb ischemia requiring re-vascularization or impending amputation
3 Untreated wound infection or osteomyelitis
4 Bleeding disorders hemophilia sickle cell disease thrombocytopenia and leukemia or blood dyscrasias
5 Anemia with hemoglobin level less than 100 gL will be included as exclusion criteria
6 Patient is taking immunosuppressive agents eg corticosteroids chemotherapeutic agents transplant medications
7 Current treatment for malignancy or neoplastic disease or collagen vascular disease
8 Patients taking anticoagulants like heparin or coumadin or others which may hinder in clot thrombin formation
9 Patient has a highly communicable disease or diseases that may limit follow - up eg immuno-compromised conditions hepatitis active tuberculosis
10 Ulcers resulting from electrical chemical radiation burns
11 Serum creatinine level 110 umolL
12 HbA1c 9
13 Currently participating in another investigation study
14 Ulcer with exposed bone or tendon Withdrawal Criteria
1 The patient may be withdrawn from the study at the discretion of the investigator if judged noncompliant with study procedures or worsening patient condition 2 Detection of osteomyelitis that is not treatable by debridement and antibiotics at the discretion of the investigator 3 Development of progressive wound necrosis Experimental Methods For study purposes diabetic foot ulcer will be a wound on the plantar aspect of the foot which has not responded to at least 4 weeks of best practice care Complete wound closure will be defined as skin closure 100 re-epithelization without drainage or dressing requirements
Patients seeking treatment for diabetic foot ulcers that meet the entry criteria will be considered for the study Patients will be randomized to either the STUDY or the CONTROL group with a 11 control to study ratio
STUDY Group Patients will have APG autologous platelet gel applied to the wound in accordance with institutional treatment protocols and manufacturers guidelines Dressing changes will occur at least three times a week
Method of preparing and application of autologous platelet gel is as follows -
1 Obtain 54 cc of whole blood into a 60 cc syringe with 6 cc of citrate anticoagulant through standard blood draw technique
2 Slowly load blood filled syringe into GPS II units centre port And centrifuge for 15 minutes
3 Draw PRP Platelet Rich Plasma concentrate from GPS II unit into a 10 cc syringe
4 Prepare the wound bed through sharp excision of the eperbole necrotic tissue wound bed
5 Aspirate PPP Platelet Poor Plasma from GPSII unit in to a 30 ml syringe
6 Inject Thrombin Reagent 5 cc of CaCl2 to Thrombin Processing Device and then add 11 cc of the PPP from the syringe and after mixing let it stand for 20 minutes
7 Draw 1 cc of thrombinCaCl2 solution into a 1 cc syringe from Thrombin Processing Device
8 Connect syringe with PRP and syringe with thrombinCaCl2 to a dual sprayer
9 Spray solutions over entire wound bed Protect surrounding skin but not into the wound with barrier film
10 Apply a semi-permeable film-type dressing as primary dressing Leave dressing in place for 3-7 days
11 The affected limb will receive offloading in the form of a total contact cast a pneumatic walking cast or wheelchair
12 After the first dressing with APG the wound will be dressed with a moist dressing similar to control group dressings The dressings will be changed daily or on a Monday-Wednesday-Friday routine based on the level of exudates
CONTROL Group
Weekly standard therapy alone as follows
1 Any debridement deemed necessary is performed
2 Ulcer-site will be dressed with a moist dressing such as cadexamer iodine ointment Iodosorb and an absorbent covering dressing that is moisture retentive Acceptable other control group dressing types are alginates hydrogels and hydrocolloids and saline gauze The dressing will be changed daily or on a Monday-Wednesday-Friday routine based on the level of exudate
3 The affected limb will receive offloading in the form of a total contact cast a pneumatic walking cast or wheelchair
Treatment Phase of the Study Treatment in both groups will continue until the wound is successfully closed
At 12 weeks 3 months wounds from both control and treatment groups will be evaluated If the wound does not show any signs of improvement wound closure by 50 at 3 months the wound will be considered as a treatment failure and it will be treated with alternate dressing according to hospital standard of care These wounds will be followed every month till they close
6-Month and 12 month follow-up For patients who achieved wound closure at 12 weeks or later the wound site will undergo an examination for recurrence
No patient will remain in the study for longer than 12 months total study duration
Clinical Assessments A Wound Debridement All wounds under study will be surgically debrided The wound may be debrided by autolysis or sharp wound debridement as tolerated
B Laboratory Testing Up to seven days prior to the initiation of protocol treatment blood samples will be taken to determine serum pre-albumin albumin and creatinine levels If the pre-albumin is 16 mgdl 160 mgL or the albumin level is 3 gdl 30 gL nutritional supplementation will be started The tests will be repeated at 12 weeks or at the time of wound closure which ever comes first Determination of HbA1c will be performed up to 30 days prior to initiation of protocol treatment and at 12 weeks or at the time of wound closure which ever comes first
Bacterial culture will be done at Day 0 Additional cultures may be obtained as clinically indicated
C Wound Examination Ulcers will be examined at Days 0 7 1 wk 14 2wk 28 4wk 56 8wk 84 12wk 6 and 12 month follow up visits
The ulcer will be classified using the University of Texas Scale Diabetic Foot ulcer Classification System
The ulcer will be evaluated using following criteria
Time to closure
Granulation tissue formation will be categorically estimated in percentages and recorded as 0-10 11-25 26-50 51-75 or 75-100
Eschar and necrotic tissue estimation
Wound edge evaluation - evidence of epithelial tissue
Amount scant moderate copious and quality serous purulent sanguinous of wound exudate
Evidence of infection erythema odor pain at ulcer site ulcer deterioration
Wound assessment will be done to include measurement of standard wound width length and depth Wound tracings will be performed using the Visitrak and depth will be measured by the placement of a wooden end of sterile cotton tipped applicator into the deepest part of the wound withdrawing and measuring that length
Ulcer photographs will be taken using a digital camera D Wound Pain Assessments - The patient will complete the wound pain assessment using a visual analog scale VAS at all study visits The pain assessment will be done prior to and within one-half hour after the wound dressing changes Pain medication use will be documented
E Documentation of Dressings - The number and type of dressings used will be documented by the health care professional taking care of the patient
F Cost - Frequency of dressing changes and estimates of material cost and nursing time will be documented Data CollectionStudy Visit Procedures Visit 1 Day -7 to Day 0 Screening Patients will be screened and data will be collected for demographic details relevant medical and surgical history lab values results of vascular studies and Plastic and or Orthopedic Surgeons consultations Visit 2 Day 0 RandomizationTreatment It will take place within 7 days after Visit 1 Patients will be randomized Wounds will be assessed photographed and measured and data will be collected
Visit 3 4 5 6 and 7 week 1 05 days week 2 4 8 and 12 Wounds will be assessed photographed and measured and data will be collected Number of dressing changes per week materials used and the occupation of person performing the dressing change will be documented The time to definitive wound closure will be recorded Pre-albumin albumin creatinine and HbA1c will be tested at week 12 Ulcer recurrence and its cause will be documented
Visit 8 and 9 6 Month and12 Month Follow-up Assessment of Recurrence These visits will occur at 6 months and 12 months for both treatment groups The wound will be examined for recurrence or determination of wound status Information about patients quality of life using Cardiff Wound Impact questionnaire 6 months after healing of the ulcer will be collected
Adverse Events Through out the study period adverse events also termed study events and adverse experiences and serious adverse events will be recorded
Statistical Analysis Endpoints will include time to 25 percent closure at 6 weeks time to 50 closure at 12 weeks and time to definitive closure Analyses will include - time to 50-percent-closure time to definitive closure percentage of wounds closed at study calendar time pointsvisits number of dressing changes and impact of diabetic foot ulcer on the quality of life Survival analysis ANOVAANCOVA and non-parametric analysis will be used A repetitive measurement analysis will also be applied Ordinal Categorical Analysis will be performed on data from Cardiff Wound Impact Schedule
Specific Aims Primary - Facilitation of healing of diabetic foot ulcers Secondary - Reduction in amputations and average total cost of care Determine the impact of diabetic ulcers on patients quality of life Research Background Foot ulcers represent a significant common complication in patients with diabetes It is estimated that twenty percent of all patients with diabetes develop a foot ulcer which may subsequently lead to below knee amputation 85 of them preceded by non-healing foot ulcers
Health care costs associated with diabetic foot wound management are staggering Armstrong et al 1998 reported that wound care for foot ulcer patients over a two year period had mean cost of 2700000 US In Toronto the average cost of below knee amputations including hospitalization and rehabilitation is 4000000
Wound healing in the context of diabetes is a challenge for both the health care provider and the patient In a systematic review conducted by Margolis et al 1999 wound healing outcomes using best practices have yielded only 24 at 12 weeks 31 in 20 weeks
Falanga Sabolinski 2001 identified that initial wound size reduction of 01 cmweek is highly predictive of wound closure whereas initial healing rates 006 cm or less predict non-healing Similarly 51 percent reduction in 4 weeks was found to be a good predictor of achieving wound closure Margolis et al 1999 Some wounds do not respond and considerable effort has been directed at therapies to improve the rate of healing in this situation
A variety of growth factors which have been used to stimulate wound healing Human platelets are an autologous source which probably can stimulate healing Autologous platelet gel APG is a material presently utilized as a tissue adhesive It is derived from platelet rich plasma PRP that was first developed in the early 1990s to primarily address acute surgical hemostatic and wound healing problems
APG is prepared by centrifugation of autologous human whole blood which initially separates it into three components packed red cells platelet poor plasma and platelet rich plasma PRP PRP has two to eight times the normal concentration of platelets in human blood The key element that differentiates APG from traditional fibrin glue is the presence of concentrated platelets rich in platelet growth factors These important elements of the blood in an increased concentration are potentially helpful in improving the rate of wound healing This study will investigate the potential improvement in wound healing with APG in diabetic foot ulcers
Rationale for the Research
To determine if topical APG autologous platelet gel is beneficial in the treatment of diabetic foot ulcers
To determine if it will result in a faster rate of wound healing
To determine if it will improve the quality of life in patients with diabetic foot ulcers Study Population Subjects for this study will be recruited from our patient population Fifty patients will be randomized to one of the two treatment groups 9 study and control
Inclusion Criteria
1 18 years of age
2 Type I or Type II Diabetes
3 Plantar forefoot ulcers beneath metatarsal head or toe ulcer which has been present for at least 4 weeks and has received best practice care
4 Evidence of adequate arterial perfusion Toe plethysmography reading of 45 mmHg or Transcutaneous oxygen measurement of 30mmHg
5 Patient is appropriately offloaded contact cast pneumatic walking cast
6 Infection andor osteomyelitis have been ruled out or are being treated
7 Platelet count greater than150000mm3
8 Orthopedic assessment has been completed to rule out mechanical source of ulceration
9 Patients with following skeletal deformities could be included -
1 Tendoachillis contracture - after tendoachillis contracture lengthening has been done
2 Charcot arthropathy with concurrent surgical intervention
3 Toe deformities hallus valgus significant claw toe deformities withafter surgical intervention
4 Major axial malalignment hindfoot varusvalgas pes planus pes cavus withafter surgical intervention
10 Patients taking clopidogrel Plavix and aspirin could be included in the study Patients taking aspirin for non medical reason will be asked to discontinue the medicine one week before the start of treatment
Exclusion Criteria
1 TcPO2 30 mmHg andor toe plethysmography readings of less than 45 mmHg
2 Limb ischemia requiring re-vascularization or impending amputation
3 Untreated wound infection or osteomyelitis
4 Bleeding disorders hemophilia sickle cell disease thrombocytopenia and leukemia or blood dyscrasias
5 Anemia with hemoglobin level less than 100 gL will be included as exclusion criteria
6 Patient is taking immunosuppressive agents eg corticosteroids chemotherapeutic agents transplant medications
7 Current treatment for malignancy or neoplastic disease or collagen vascular disease
8 Patients taking anticoagulants like heparin or coumadin or others which may hinder in clot thrombin formation
9 Patient has a highly communicable disease or diseases that may limit follow - up eg immuno-compromised conditions hepatitis active tuberculosis
10 Ulcers resulting from electrical chemical radiation burns
11 Serum creatinine level 110 umolL
12 HbA1c 9
13 Currently participating in another investigation study
14 Ulcer with exposed bone or tendon Withdrawal Criteria
1 The patient may be withdrawn from the study at the discretion of the investigator if judged noncompliant with study procedures or worsening patient condition 2 Detection of osteomyelitis that is not treatable by debridement and antibiotics at the discretion of the investigator 3 Development of progressive wound necrosis Experimental Methods For study purposes diabetic foot ulcer will be a wound on the plantar aspect of the foot which has not responded to at least 4 weeks of best practice care Complete wound closure will be defined as skin closure 100 re-epithelization without drainage or dressing requirements
Patients seeking treatment for diabetic foot ulcers that meet the entry criteria will be considered for the study Patients will be randomized to either the STUDY or the CONTROL group with a 11 control to study ratio
STUDY Group Patients will have APG autologous platelet gel applied to the wound in accordance with institutional treatment protocols and manufacturers guidelines Dressing changes will occur at least three times a week
Method of preparing and application of autologous platelet gel is as follows -
1 Obtain 54 cc of whole blood into a 60 cc syringe with 6 cc of citrate anticoagulant through standard blood draw technique
2 Slowly load blood filled syringe into GPS II units centre port And centrifuge for 15 minutes
3 Draw PRP Platelet Rich Plasma concentrate from GPS II unit into a 10 cc syringe
4 Prepare the wound bed through sharp excision of the eperbole necrotic tissue wound bed
5 Aspirate PPP Platelet Poor Plasma from GPSII unit in to a 30 ml syringe
6 Inject Thrombin Reagent 5 cc of CaCl2 to Thrombin Processing Device and then add 11 cc of the PPP from the syringe and after mixing let it stand for 20 minutes
7 Draw 1 cc of thrombinCaCl2 solution into a 1 cc syringe from Thrombin Processing Device
8 Connect syringe with PRP and syringe with thrombinCaCl2 to a dual sprayer
9 Spray solutions over entire wound bed Protect surrounding skin but not into the wound with barrier film
10 Apply a semi-permeable film-type dressing as primary dressing Leave dressing in place for 3-7 days
11 The affected limb will receive offloading in the form of a total contact cast a pneumatic walking cast or wheelchair
12 After the first dressing with APG the wound will be dressed with a moist dressing similar to control group dressings The dressings will be changed daily or on a Monday-Wednesday-Friday routine based on the level of exudates
CONTROL Group
Weekly standard therapy alone as follows
1 Any debridement deemed necessary is performed
2 Ulcer-site will be dressed with a moist dressing such as cadexamer iodine ointment Iodosorb and an absorbent covering dressing that is moisture retentive Acceptable other control group dressing types are alginates hydrogels and hydrocolloids and saline gauze The dressing will be changed daily or on a Monday-Wednesday-Friday routine based on the level of exudate
3 The affected limb will receive offloading in the form of a total contact cast a pneumatic walking cast or wheelchair
Treatment Phase of the Study Treatment in both groups will continue until the wound is successfully closed
At 12 weeks 3 months wounds from both control and treatment groups will be evaluated If the wound does not show any signs of improvement wound closure by 50 at 3 months the wound will be considered as a treatment failure and it will be treated with alternate dressing according to hospital standard of care These wounds will be followed every month till they close
6-Month and 12 month follow-up For patients who achieved wound closure at 12 weeks or later the wound site will undergo an examination for recurrence
No patient will remain in the study for longer than 12 months total study duration
Clinical Assessments A Wound Debridement All wounds under study will be surgically debrided The wound may be debrided by autolysis or sharp wound debridement as tolerated
B Laboratory Testing Up to seven days prior to the initiation of protocol treatment blood samples will be taken to determine serum pre-albumin albumin and creatinine levels If the pre-albumin is 16 mgdl 160 mgL or the albumin level is 3 gdl 30 gL nutritional supplementation will be started The tests will be repeated at 12 weeks or at the time of wound closure which ever comes first Determination of HbA1c will be performed up to 30 days prior to initiation of protocol treatment and at 12 weeks or at the time of wound closure which ever comes first
Bacterial culture will be done at Day 0 Additional cultures may be obtained as clinically indicated
C Wound Examination Ulcers will be examined at Days 0 7 1 wk 14 2wk 28 4wk 56 8wk 84 12wk 6 and 12 month follow up visits
The ulcer will be classified using the University of Texas Scale Diabetic Foot ulcer Classification System
The ulcer will be evaluated using following criteria
Time to closure
Granulation tissue formation will be categorically estimated in percentages and recorded as 0-10 11-25 26-50 51-75 or 75-100
Eschar and necrotic tissue estimation
Wound edge evaluation - evidence of epithelial tissue
Amount scant moderate copious and quality serous purulent sanguinous of wound exudate
Evidence of infection erythema odor pain at ulcer site ulcer deterioration
Wound assessment will be done to include measurement of standard wound width length and depth Wound tracings will be performed using the Visitrak and depth will be measured by the placement of a wooden end of sterile cotton tipped applicator into the deepest part of the wound withdrawing and measuring that length
Ulcer photographs will be taken using a digital camera D Wound Pain Assessments - The patient will complete the wound pain assessment using a visual analog scale VAS at all study visits The pain assessment will be done prior to and within one-half hour after the wound dressing changes Pain medication use will be documented
E Documentation of Dressings - The number and type of dressings used will be documented by the health care professional taking care of the patient
F Cost - Frequency of dressing changes and estimates of material cost and nursing time will be documented Data CollectionStudy Visit Procedures Visit 1 Day -7 to Day 0 Screening Patients will be screened and data will be collected for demographic details relevant medical and surgical history lab values results of vascular studies and Plastic and or Orthopedic Surgeons consultations Visit 2 Day 0 RandomizationTreatment It will take place within 7 days after Visit 1 Patients will be randomized Wounds will be assessed photographed and measured and data will be collected
Visit 3 4 5 6 and 7 week 1 05 days week 2 4 8 and 12 Wounds will be assessed photographed and measured and data will be collected Number of dressing changes per week materials used and the occupation of person performing the dressing change will be documented The time to definitive wound closure will be recorded Pre-albumin albumin creatinine and HbA1c will be tested at week 12 Ulcer recurrence and its cause will be documented
Visit 8 and 9 6 Month and12 Month Follow-up Assessment of Recurrence These visits will occur at 6 months and 12 months for both treatment groups The wound will be examined for recurrence or determination of wound status Information about patients quality of life using Cardiff Wound Impact questionnaire 6 months after healing of the ulcer will be collected
Adverse Events Through out the study period adverse events also termed study events and adverse experiences and serious adverse events will be recorded
Statistical Analysis Endpoints will include time to 25 percent closure at 6 weeks time to 50 closure at 12 weeks and time to definitive closure Analyses will include - time to 50-percent-closure time to definitive closure percentage of wounds closed at study calendar time pointsvisits number of dressing changes and impact of diabetic foot ulcer on the quality of life Survival analysis ANOVAANCOVA and non-parametric analysis will be used A repetitive measurement analysis will also be applied Ordinal Categorical Analysis will be performed on data from Cardiff Wound Impact Schedule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None