Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Device: Orion TM Amniotic Membrane AllograftProcedure: Standard of Care (SOC)
- Registration Number
- NCT06420245
- Lead Sponsor
- Legacy Medical Consultants
- Brief Summary
The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves wound healing.
During the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.
- Detailed Description
Lower extremity diabetic ulcers are a common complication affecting millions of people in the United States. The purpose of this study is to evaluate the clinical utility of Orion™, a dual-layer amniotic membrane allograft, versus standard wound care in the management of diabetic foot ulcers. Amniotic membrane allografts are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271 for the management of diabetic foot ulcers. Investigators hypothesize that the group of participants who receive amniotic membrane allografts in addition to standard wound care will experience a faster rate and higher incidence of complete wound closure compared to standard wound care alone. For only partially healed wounds, investigators anticipate a statistically significant reduction in the size of the ulcer and improved quality of life for participants in the experimental arm compared to standard wound care alone.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amniotic Membrane plus Standard of Care Orion TM Amniotic Membrane Allograft Biweekly application of Orion TM amniotic membrane allograft in addition to standard of care DFU wound management Amniotic Membrane plus Standard of Care Standard of Care (SOC) Biweekly application of Orion TM amniotic membrane allograft in addition to standard of care DFU wound management Standard of Care (SOC) Standard of Care (SOC) Standard of care DFU wound management
- Primary Outcome Measures
Name Time Method Incidence of Complete Wound Closure starting from randomization until last visit of the 12-week wound management period Percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization.
- Secondary Outcome Measures
Name Time Method Time to complete wound closure From time of randomization until the end of the twelve (12) week Wound Management Period. time to 100% re-epithelialization of the index ulcer without leaking exudate as assessed by Kare inSight®, starting at randomization through identification of complete wound closure.
Incidence of complete wound closure From time of randomization to eight (8) weeks post-randomization. Incidence of complete wound closure, defined as 100% re-epithelialization of the index ulcer without leaking exudate as assessed by eKare inSight® at eight (8) weeks post-randomization.
Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure. From the time of randomization through the twelve (12) week Wound Management Period. The number of Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure during twelve (12) week Wound Management Period.
Change in Quality of Life metrics starting from randomization to last visit of the 12-week wound management period Change in QoL metrics at twelve (12) weeks post-randomization compared to baseline as reported by the subject in the WOUND-Q QoL questionnaires: Life Impact (8-32; higher is better); Lower Limb Symptoms (10-40; higher is better)
Recurrence Within Six Months starting from last visit of the 12-week wound management period until 6-month follow-up visit Recurrence within six (6) months post wound managment period completion, defined as meeting the primary endpoint and reopening of index ulcer at the same site within six (6) months.
Change in wound size from the time of randomization through twelve (12) weeks post-randomization. Percent area change of index ulcer at completion of twelve (12) weeks post-randomization.
Change in QoL metrics in follow-up. From time of completion of the Wound Management Period through six (6) months. Change in QoL metrics to six (6) months after completion of the Wound Management Period as reported by the patient in the WOUND-Q QoL questionnaire.
Adverse events From the time of randomization through six (6) month follow-up. Adverse events from randomization through six (6) month follow-up.
Serious adverse events From the time of randomization through six (6) month follow-up. Occurrence of serious adverse events (SAEs) from randomization through six (6) month follow-up.
Major amputations From the time of randomization through six (6) month follow-up. Major amputations defined as amputation above the metatarsals.
Minor amputations From the time of randomization through six (6) month follow-up. Minor amputations defined as amputation involving toe or metatarsal only.
Hospital admission(s) From the time of randomization through six (6) month follow-up. Hospital admission(s) and diagnosis from randomization through six (6) month follow-up.
Emergency Department (ED) visit(s) From the time of randomization through six (6) month follow-up. ED visit(s) without admission through six (6) month follow-up.