Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.

NCT06437028 | Recruiting

• 1 other identifier: SB-24-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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 target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 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 and their quality of life.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12-weeks following study screening phase

Secondary Outcomes (5)

• Time to wound closure

  12-weeks following study screening phase

• Percent reduction in wound area

  12-weeks following study screening phase

• Reduction in Adverse Events

  12-weeks following study screening phase

• Forgotten Wound Score Measure

  12-weeks following study screening phase

• Wound Quality of life questionnaire

  12-weeks following study screening phase

Other Outcomes (1)

• Proportion of ulcers that completely heal in patients 65 years or older

  12-weeks following study screening phase

Study Arms (3)

Dual-layer perinatal tissue allograft

EXPERIMENTAL

Patients will receive weekly applications of a dual-layer perinatal tissue allograft in addition to standard of care wound management.

Other: Dual-layer perinatal tissue allograft; Other: Standard of care

Three-layer fenestrated perinatal tissue allograft

EXPERIMENTAL

Patients will receive weekly applications of a three-layer fenestrated perinatal tissue allograft in addition to standard of care wound management.

Other: Three-layer fenestrated perinatal tissue allograft; Other: Standard of care

Standard of care (SOC) wound management

ACTIVE COMPARATOR

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.

Other: Standard of care

Interventions

Dual-layer perinatal tissue allograft OTHER

The dual-layer perinatal tissue allograft is an amnion - amnion allograft

Dual-layer perinatal tissue allograft

Three-layer fenestrated perinatal tissue allograft OTHER

The three-layer fenestrated perinatal tissue allograft is an amnion - chorion - amnion allograft

Three-layer fenestrated perinatal tissue allograft

Standard of care OTHER

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.

Dual-layer perinatal tissue allograft; Standard of care (SOC) wound management; Three-layer fenestrated perinatal tissue allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects are required to meet all the following criteria for enrollment in the study.
• Subjects must be at least 18 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
• The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
• The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
• The potential subject must consent to using the prescribed offloading method for the duration of the study.
• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.
• Potential subjects meeting any of the following criteria will be excluded from enrollment in the study.
• A subject known to have a life expectancy of \< 6 months is excluded.
• The subject is excluded if the target ulcer is not secondary to diabetes.
• If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
• A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
• The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.

Sponsors & Collaborators

• Samaritan Biologics: lead
• Serena Group: collaborator

Study Sites (1)

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Leg Ulcer; Diabetes Complications; Skin Ulcer; Peripheral Arterial Disease; Ischemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas E Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy J Mercuri, PhD

CONTACT

484-883-2033; jmercuri@samaritanbiologics.com

Jerry Chang, BS

CONTACT

352-256-2707; jchang@samaritanbiologics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be modified platform design in which two treatment groups will be compared to one control group initially. However, this study design will enable the inclusion of additional study groups over time while concomitantly increasing the control group size to maintain adequate power.

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: May 9, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)