Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management

Not Applicable

Withdrawn

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Orion TM Amniotic Membrane Allograft; Procedure: 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 TM, 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 main question it aims to answer is 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 patient outcomes.

Participants will visit their doctor weekly over a 12 week period, as per standard 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 TM, 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.

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Status Verified: 2024-10
• Study Start: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-02
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients ≥ 50 and ≤ 85 years of age;

• Willing and able to provide informed consent;

• Willing and able to comply with study requirements;

• Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus

• Non-study ulcers must be > 2 cm (.79 in.) from the index ulcer;

• Index DFU identified ≥ 4 weeks prior to study screening and < 52 weeks from the date of informed consent;

• Index DFU area > 1.0 cm2 (0.39 in.) and < 25 cm2 (9.84 in.) at screening and at final visit of run-in period;

• Index DFU offloaded according to SOC for ≥ 14 days prior to randomization;

• Index foot has adequate circulation defined as meeting one (1) of the following within 30 days of screening:

  1. ABI ≥0.7 and ≤1.3 AND TBI >0.6;
  2. Dorsum transcutaneous oxygen tension measurement (TcPO2) ≥30 mmHg;
  3. Arterial duplex with biphasic flow in BOTH the DP and PT arteries.

Exclusion Criteria

• Index ulcer reduced in area by > 20% at the end of the 4-week run-in period;

• Presence of active osteomyelitis or bone infection as verified by x-ray or MRI ≤ 30 days of study wound management visit #1/ Week #1 of the run-in period;

• Raynaud's disease;

• Unreconstructible arterial ischemia which may lead to nonhealing

• Treatment with immunosuppressants, including systemic corticosteroids for ≥ 2 weeks within 30 days prior to study screening, or are anticipated during study participation;

• Any active cancer undergoing treatment ≤ 30 days prior to treatment visit #1 of the run-in period, or is anticipated during study participation;

• Treatment with chemotherapy within 30 days of the first study treatment visit of the run-in period, or is anticipated during study participation;

• Diabetics with poor metabolic control, defined as HbA1c ≥ 12.0%, ≤ 30 days of study treatment visit #1 of the run-in period;

• Participation in an investigational device, biologic, or drug study currently or within 30 days of study treatment visit #1 of the run-in period;

• Prior use of any advanced skin substitute product on the index ulcer ≤ 60 days of study treatment visit #1 of the run-in period;

• Index ulcer was continued to be treated after visit #1 of the run-in period and/or anticipate treatment during study participation with any of the following prohibited therapies:

  1. Biomedical or topical growth factor;
  2. Topical steroids applied to the index ulcer surface;
  3. On medications that are considered immune system modulators that could affect graft incorporation;
  4. Scarlet red dressing;
  5. Dakin's solution;
  6. Mafenide acetate;
  7. Tincoban;
  8. Zinc sulfate;
  9. Povidone-iodine solution;
  10. Mafenide acetate;
  11. Polymyxin/nystatin;
  12. Chlorhexidine;

• Patient is taking a cyclooxygenase-2 inhibitor (COX-2 inhibitor); such as, celecoxib (Celebrex, Consensi, Elyxyb), valdecoxib (Bextra), amlodipine (Consensi);

• Patient has serum creatinine > 2.5 mg/dL ≤ 30 days of study treatment visit #1 of the run-in period;

• Autoimmune connective tissue disease;

• End stage renal disease (ESRD);

• Presence of any condition which would seriously compromise the subject's ability to complete this study;

• Known history of poor adherence to medical therapy and/or clinic appointments;

• Life expectancy < 1 year.

Exclusion Criteria

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 12-week wound management period	time to 100% re-epithelialization of the index ulcer without leaking exudate, starting at randomization through positive assessment of complete wound closure.
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.