## Protocol Section
### Identification Module
**NCT ID:** NCT06420245

**Acronym:** REBOUND

**Brief Title:** Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management

**Official Title:** A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate the Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer (DFU) Wound Management

#### Organization Study ID Info
**ID:** LEGACYMED-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Legacy Medical Consultants
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Legacy Medical Consultants

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetic Foot Ulcer

**Keywords:**

- amniotic membrane allograft

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Standard wound care procedures

**Intervention Names:**

- Procedure: Standard of Care (SOC)

**Label:** Standard of Care (SOC)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Application of Orion TM amniotic membrane allograft in addition to standard wound care for DFUs

**Intervention Names:**

- Device: Orion TM Amniotic Membrane Allograft

- Procedure: Standard of Care (SOC)

**Label:** Amniotic Membrane plus Standard of Care

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Amniotic Membrane plus Standard of Care

**Description:** The intervention is a sterile allograft made from dehydrated extracellular matrix, designed to promote wound healing by providing a reliable and protective wound covering. Amniotic membranes are hypothesized to promote healing in open wounds by serving as a scaffold to support native tissue ingrowth, encouraging angiogenesis, and limiting microbial spread.

**Name:** Orion TM Amniotic Membrane Allograft

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Amniotic Membrane plus Standard of Care

- Standard of Care (SOC)

**Description:** Standard wound care entails surgical debridement to remove all necrotic tissue, screening for infection and probing of the wound for bone, application of a collagen alginate primary dressing, and off-loading using a removable diabetic offloading cam-walker.

**Name:** Standard of Care (SOC)

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization.

**Measure:** Incidence of Complete Wound Closure

**Time Frame:** 12 weeks after randomization into study arm following a 4-week run-in period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Subject age is between 50-80 years old
2. Presence of Wagner 1 DFU extending at least through the dermis provided it was below the aspect of the medial malleolus, and if multiple Wagner 1 DFUs present, then the largest ulcer was evaluated as the index ulcer in the study with other ulcers being more than 2 cm from the index
3. Index ulcer duration ≥4 weeks prior to the study screening but \<52 weeks as of the date of consent
4. Index ulcer area \>1.0 cm2 and \<25 cm2 at screening visit and first treatment visits
5. Index ulcer offloaded for ≥14 days prior to randomization
6. Affected foot had adequate circulation (defined as a dorsal transcutaneous oximetry measurement (TCOM) or a skin perfusion pressure measurement of ≥30 mmHg, OR an ankle brachial index (ABI) of ≥0.7 and ≤1.3 within 3 months of screening, OR arterial Doppler with a minimum of biphasic flow in the dorsalis pedis and posterior tibial vessels at the level of the ankle, OR a toe brachial index (TBI) of \>0.6)
7. Women of childbearing potential complied with contraception use and pregnancy tests for the study duration
8. Demonstration of understanding and willingness to participate in the study, ability to comply with the weekly visits and follow-up, and provided written informed consent.
9. Meets screening criteria 30 days following first run-in visit.

Exclusion Criteria:

1. Index ulcer deemed to be caused by a medical condition other than diabetes
2. Index ulcer is potentially or confirmed by biopsy to be cancerous
3. Subject is afflicted with Raynaud's disease
4. Arterial ischemia is a potential cause of foot ulcerations
5. Presence of active osteomyelitis or bone infection as verified by x-ray within 30 days prior to randomization
6. An infected foot ulcer on the index foot requiring use of antibiotics;
7. Subject exhibits poor metabolic control (HbA1c ≥ 12.0) within 90 days of randomization
8. Participation in an investigational device or drug study currently or within 30 days of screening
9. More than 2 weeks of treatment with immunosuppressants, including systemic corticosteroids and/or topical steroids applied to the index ulcer surface within 1 month prior to screening, or are anticipated during study participation;
10. Treated with cytotoxic chemotherapy within one month prior to screening, or is anticipated during study participation
11. Index ulcer site has undergone radiation therapy
12. Presence of any condition which would seriously compromise the subject's ability to complete this study
13. Known history of poor adherence to medical therapy and/or clinic appointments
14. Subject is taking a selective COX-2 inhibitor
15. Subject has serum creatinine \> 3.0 mg/dL within 120 days of randomization
16. Subject is non-ambulatory
17. Failure to meet screening criteria within 30 days of first run-in visit, including index ulcer reduced in area by 20% or more after 28 days of SOC during the run-in period.

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jennifer@legacymedicalconsultants.com

**Name:** Jennifer Linksy

**Phone:** 813-600-9290

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003925

- Term: Diabetic Angiopathies

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000007871

- Term: Leg Ulcer

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000003929

- Term: Diabetic Neuropathies

- ID: D000005534

- Term: Foot Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulcer

- ID: M19933

- Name: Diabetic Foot

- Relevance: HIGH

- As Found: Diabetic Foot

- ID: M18919

- Name: Foot Ulcer

- Relevance: HIGH

- As Found: Foot Ulcer

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10883

- Name: Leg Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7124

- Name: Diabetic Neuropathies

- Relevance: LOW

- As Found: Unknown

- ID: M8658

- Name: Foot Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017719

- Term: Diabetic Foot

- ID: D000016523

- Term: Foot Ulcer

- ID: D000014456

- Term: Ulcer

### Misc Info Module

- Version Holder: 2024-05-31
