## Protocol Section
### Identification Module
**NCT ID:** NCT06437028

**Brief Title:** Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.

**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.

#### Organization Study ID Info
**ID:** SB-24-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Samaritan Biologics
### Status Module
#### Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Emergent Clinical Consulting, LLC

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Samaritan Biologics

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 (i.e. healing) as compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment.

One ulcer on each participant's 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 Administration's 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 (i.e. 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.

### Conditions Module

**Conditions:**

- Diabetic Foot Ulcer

**Keywords:**

- Diabetes

- Diabetic Foot

- Allograft

- Amnion

- Chorion

- Wound healing

- Advanced wound care

- Comparative effectiveness

- Lower extremity ulcer

- Time to heal

- Treatment

- Diabetes complication

- Skin ulcer

- Neuropathy

- Peripheral artery disease

- Ischemia

- Wagner Grade

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 180

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive weekly applications of multilayer perinatal tissue allograft in addition to standard of care wound management.

**Intervention Names:**

- Other: Multilayer perinatal tissue allograft

- Other: Standard of care

**Label:** Multilayer perinatal tissue allograft

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients will receive weekly applications of a full thickness perinatal tissue allograft in addition to standard of care wound management.

**Intervention Names:**

- Other: Full thickness perinatal tissue allograft

- Other: Standard of care

**Label:** Full thickness perinatal tissue allograft

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.

**Intervention Names:**

- Other: Standard of care

**Label:** Standard of care (SOC) wound management

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Multilayer perinatal tissue allograft

**Description:** The multilayer perinatal tissue allograft is an amnion - amnion allograft

**Name:** Multilayer perinatal tissue allograft

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Full thickness perinatal tissue allograft

**Description:** The full thickness perinatal tissue allograft is an amnion - intermediate layer - amnion allograft

**Name:** Full thickness perinatal tissue allograft

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Full thickness perinatal tissue allograft

- Multilayer perinatal tissue allograft

- Standard of care (SOC) wound management

**Description:** Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.

**Name:** Standard of care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm\^2 as determined by the site investigator and validated by a blinded review board.

**Measure:** Incidence of Complete Wound Closure

**Time Frame:** 6- and 12-weeks following study screening phase

#### Secondary Outcomes

**Description:** Time to complete healing within 12 weeks will be determined via a Kaplan-Meier analysis

**Measure:** Time to complete healing

**Time Frame:** 12-weeks following study screening phase

**Description:** Percent reduction of wound area \[(Ai-Axw\]) / Ai\] x100, where Ai is the area of the index wound at randomization, Axw is the wound area at 4 and 12 weeks.

**Measure:** Percent reduction in wound area

**Time Frame:** 4- and 12-weeks following study screening phase

**Description:** Will determine if and when an ulcer occurs again at the same location of the index ulcer via monitoring of the ulcer site

**Measure:** Incidence of ulcer recurrence

**Time Frame:** Up to 3-months following complete healing or from the conclusion of the 12-week treatment phase (which ever occurs first)

**Description:** The average number of allografts used to achieve complete healing will be calculated

**Measure:** Average number of allografts used

**Time Frame:** 12-weeks following study screening phase

**Description:** Wound-QoL questionnaire on quality of life with chronic wounds

**Measure:** Wound Quality of life questionnaire

**Time Frame:** 12-weeks following study screening phase

**Description:** Unfavorable outcome during the study directly related to the index wound and graft (cellulitis, osteomyelitis, infection of the treated extremity, etc...)

**Measure:** Serious adverse events

**Time Frame:** 12-weeks following study screening phase

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female age 18 or older
* Type 1 or type 2 diabetes mellitus
* Signed informed consent
* Wound is diabetic in origin
* Ulcer duration of ≥ 4 weeks \[i.e. recalcitrant/unresponsive to SOC (\<50% decrease in size when treated with standard of care), but wound duration not longer than 1 year\] with documented failure of prior treatment to heal the wound
* Wound size: 1 cm2 - 25 cm2
* Wound present anatomically on the foot as defined by beginning below the malleoli of the ankle and located on the plantar surface
* No clinical signs of infection
* Wound does not extend into tendon or bone and no evidence of osteomyelitis (Wagner Score: Grade 1)
* Additional wounds may be present but should not be within 3 cm of the index / study wound so that coalescence cannot occur
* Serum creatinine \< 3.0 mg/dL
* HbA1c \< 12% at randomization
* Patient should exhibit adequate vascular perfusion to affected extremity determined within 1 month of screening via one or a combination of the following:
* Ankle-brachial index (ABI) with results of ≥ 0.70 and ≤ 1.2 mm Hg.
* If medial calcinosis is suspected, a toe-brachial index ≥ 0.70 should be evaluated in the patient in lieu of ABI
* Toe systolic blood pressure of \> 30mm HG
* Doppler arterial waveforms which are triphasic or biphasic at the ankle of the infected leg
* Toe pressure transcutaneous oximetry: ≥ 60mm Hg
* Patient is of legal consenting age
* Patient is willing to provide informed consent and is willing to participate in all procedures and follow-up evaluations necessary to complete study.

Exclusion Criteria:

* Wound extending to tendon or bone
* Index wound greater than 25 cm2
* HbA1c \> 12% within previous 90 days
* Serum creatinine level 3.0 mg/dL or greater (indicative or renal impairment)
* Patients with a known history of poor compliance with medical treatments
* Patients previously randomized into this study, or presently participating in another clinical trial
* Patients currently receiving radiation therapy or chemotherapy
* Patient with known or suspected local skin malignancy to the index wound
* Patients with uncontrolled autoimmune connective tissue diseases
* Non-revascularizable surgical sites
* Active infection at wound site
* Presence of a Charcot abnormality
* Any pathology that would limit the blood supply and compromise healing
* Patients who have received a biomedical or topical growth factor for their wound within the previous 30 days
* Patients who are pregnant or breast feeding
* Patients who are taking medications that are considered immune system modulators that could affect graft incorporation
* Patients taking a Cox-2 inhibitor
* Patients with wound healing \>20% during the screening period

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jmercuri@samaritanbiologics.com

**Name:** Jeremy J Mercuri, PhD

**Phone:** 484-883-2033

**Role:** CONTACT

**Contact 2:**

**Email:** jchang@samaritanbiologics.com

**Name:** Jerry Chang, BS

**Phone:** 352-256-2707

**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: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue 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: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M19933

- Name: Diabetic Foot

- Relevance: HIGH

- As Found: Diabetic Foot

- ID: M18919

- Name: Foot Ulcer

- Relevance: HIGH

- As Found: Foot Ulcer

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: LOW

- As Found: Unknown

- ID: M10883

- Name: Leg Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- 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

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
