Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers
Sponsor:
Samaritan Biologics
Organization:
Samaritan Biologics
Study Overview
Official Title:
A Multicenter Prospective Randomized Controlled Evaluation of the Efficacy of Perinatal Membrane Allografts as Adjuncts to Standard of Care Versus Standard of Care Alone for the Treatment of Diabetic Foot Ulcers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic non-healing foot ulcers in diabetic patients
The main question that this study aims to answer is
Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of patients achieving complete wound closure ie healing as compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment
One ulcer on each participants foot will receive weekly 1 applications of perinatal tissue allografts and standard of care wound management or 2 standard of care wound management alone Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks Additionally the participants will be asked to fill out a questionnaire about the wound impacts their life
The main question that this study aims to answer is
Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of patients achieving complete wound closure ie healing as compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment
One ulcer on each participants foot will receive weekly 1 applications of perinatal tissue allografts and standard of care wound management or 2 standard of care wound management alone Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks Additionally the participants will be asked to fill out a questionnaire about the wound impacts their life
Detailed Description:
Patients with diabetes often develop ulcers on their lower extremities While some ulcers can be managed using standard of care wound management techniques including debridement moist dressings infection control and off-loading many develop into chronic non-healing wounds Chronic non-healing wounds can lead to higher risk of infection amputation and decreased quality of life
Advanced wound therapies aim to promote rapid and complete healing of chronic wounds An example of an advanced wound therapy are perinatal tissue allografts These include human amniotic chorionic membranes which have been confirmed by the United States Food Drug Administrations Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the Public Health Service Act as defined in Title 21 of the Code of Federal Regulations - Part 1271 for the management of diabetic foot ulcers
The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of perinatal tissue allografts in addition to standard of care wound management techniques compared to applying standard of care wound management only
It is hypothesized that the addition of perinatal tissue allografts will result in a higher percentage of patients achieving complete wound closure ie healing compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment
To test this hypothesis the study will consist of patients who will undergo a 2-week screening phase a 12-week treatment phase and a follow-up phase of up to 3 months Briefly during the 2-week screening phase patients meeting inclusion criteria will have an identified index wound managed with standard of care Index wounds that are not reduced by more than 20 in the screening phase will be randomized into the treatment groups During the 12-week treatment phase index wounds will be treated weekly with either allograft and standard of care or standard of care alone During the follow-up phase the site of the index wound will be evaluated to determine recurrence of the wound
Evaluation of data outcome measures associated with the trial will include intent to treat and per protocol analyses which will be performed by at least one blinded statistician and investigator
Advanced wound therapies aim to promote rapid and complete healing of chronic wounds An example of an advanced wound therapy are perinatal tissue allografts These include human amniotic chorionic membranes which have been confirmed by the United States Food Drug Administrations Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the Public Health Service Act as defined in Title 21 of the Code of Federal Regulations - Part 1271 for the management of diabetic foot ulcers
The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of perinatal tissue allografts in addition to standard of care wound management techniques compared to applying standard of care wound management only
It is hypothesized that the addition of perinatal tissue allografts will result in a higher percentage of patients achieving complete wound closure ie healing compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment
To test this hypothesis the study will consist of patients who will undergo a 2-week screening phase a 12-week treatment phase and a follow-up phase of up to 3 months Briefly during the 2-week screening phase patients meeting inclusion criteria will have an identified index wound managed with standard of care Index wounds that are not reduced by more than 20 in the screening phase will be randomized into the treatment groups During the 12-week treatment phase index wounds will be treated weekly with either allograft and standard of care or standard of care alone During the follow-up phase the site of the index wound will be evaluated to determine recurrence of the wound
Evaluation of data outcome measures associated with the trial will include intent to treat and per protocol analyses which will be performed by at least one blinded statistician and investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None