Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.

Diabetic Foot Ulcer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437028
• Other study ID #: SB-24-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: Samaritan Biologics
• Contact: Jeremy J Mercuri, PhD
• Phone: 484-883-2033
• Email: jmercuri[@]samaritanbiologics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Other:
• Multilayer perinatal tissue allograft
The multilayer perinatal tissue allograft is an amnion - amnion allograft
• Full thickness perinatal tissue allograft
The full thickness perinatal tissue allograft is an amnion - intermediate layer - amnion allograft
• Standard of care
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Samaritan Biologics	Emergent Clinical Consulting, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Complete Wound Closure	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.	6- and 12-weeks following study screening phase
Secondary	Time to complete healing	Time to complete healing within 12 weeks will be determined via a Kaplan-Meier analysis	12-weeks following study screening phase
Secondary	Percent reduction in wound area	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.	4- and 12-weeks following study screening phase
Secondary	Incidence of ulcer recurrence	Will determine if and when an ulcer occurs again at the same location of the index ulcer via monitoring of the ulcer site	Up to 3-months following complete healing or from the conclusion of the 12-week treatment phase (which ever occurs first)
Secondary	Average number of allografts used	The average number of allografts used to achieve complete healing will be calculated	12-weeks following study screening phase
Secondary	Wound Quality of life questionnaire	Wound-QoL questionnaire on quality of life with chronic wounds	12-weeks following study screening phase
Secondary	Serious adverse events	Unfavorable outcome during the study directly related to the index wound and graft (cellulitis, osteomyelitis, infection of the treated extremity, etc...)	12-weeks following study screening phase