Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338923
Status:
COMPLETED
Last Update Posted:
2007-08-17
First Post:
2006-06-19
Brief Title:
Wound Healing Effects of HO0303 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers Pilot Study
Sponsor:
HealOr
Organization:
HealOr
Study Overview
Official Title:
Wound Healing Effects of HO0303 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter pilot study to assess the healing effects of HO0303 on diabetic neuropathic plantar and venous ulcers
HO0303 action mechanism involves the manipulation of keratinocyte and fibroblast migration and differentiation at the wound area
The primary end point of this study is assessment of safety in treating with HO0303 and the efficacy of the drug to promote wound closure of chronic wounds
The secondary end points are assessment time to closure and healing rate for the measurement of wound healing progression
HO0303 action mechanism involves the manipulation of keratinocyte and fibroblast migration and differentiation at the wound area
The primary end point of this study is assessment of safety in treating with HO0303 and the efficacy of the drug to promote wound closure of chronic wounds
The secondary end points are assessment time to closure and healing rate for the measurement of wound healing progression
Detailed Description:
This is a multicenter pilot study to assess the healing effects of HO0303 on diabetic neuropathic plantar and venous ulcers
Pretreatment phase During a pretreatment phase that will last up to 14 days all patients will receive the conventional treatment once a day at the discretion of the investigator All wounds will be morphologically monitored by photo documentation daily and measurements of wound area once a week
Initial study visit patients will begin treatment after completing all necessary demands in pre-treatment phase or after ruling out of all exclusion criteria All wounds will be cleaned from previous treatment by surgical debridement and irrigation saline
Treatment phase Following the pre-treatment phase wounds will be treated topically with HO0303 for 30 days During this 30 day phase patients will receive daily treatments with HO0303 either at home by a certified nurse or at the clinic Wounds will be monitored by certified medical staff member as well as photo documentation Then application of the treatment followed by a 15-minute rest Finally wound will be dressed with a fresh dressing and monitoring of any adverse events
Patients will be administered HO0303 in addition to weight off-load Once a week wounds will be monitored by a physician wounds size will be determined and documented Patients will be evaluated for pain sensation at the wound area by filling a pain scoring questionnaire
Twice during the experiment patients will undergo blood profile HbA1c blood glucose and urine samples testing at the initial and terminating visits
At the conclusion of the treatment phase the following will be completed
A physical examination
Collection of all blood and urine samples for clinical laboratory tests dip sticks
Pretreatment phase During a pretreatment phase that will last up to 14 days all patients will receive the conventional treatment once a day at the discretion of the investigator All wounds will be morphologically monitored by photo documentation daily and measurements of wound area once a week
Initial study visit patients will begin treatment after completing all necessary demands in pre-treatment phase or after ruling out of all exclusion criteria All wounds will be cleaned from previous treatment by surgical debridement and irrigation saline
Treatment phase Following the pre-treatment phase wounds will be treated topically with HO0303 for 30 days During this 30 day phase patients will receive daily treatments with HO0303 either at home by a certified nurse or at the clinic Wounds will be monitored by certified medical staff member as well as photo documentation Then application of the treatment followed by a 15-minute rest Finally wound will be dressed with a fresh dressing and monitoring of any adverse events
Patients will be administered HO0303 in addition to weight off-load Once a week wounds will be monitored by a physician wounds size will be determined and documented Patients will be evaluated for pain sensation at the wound area by filling a pain scoring questionnaire
Twice during the experiment patients will undergo blood profile HbA1c blood glucose and urine samples testing at the initial and terminating visits
At the conclusion of the treatment phase the following will be completed
A physical examination
Collection of all blood and urine samples for clinical laboratory tests dip sticks
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