RECRUITING

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

Conditions

Diabetic Foot Ulcer 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating the Efficacy of Multiple Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.

Quick Facts

Study Start:2025-04

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06437028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects must be at least 18 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. 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. 4. 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. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. 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. 7. 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: 1. ABI between 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic. 8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment. 10. The potential subject must consent to using the prescribed offloading method for the duration of the study. 11. The potential subject must agree to attend the weekly study visits required by the protocol. 12. The potential subject must be willing and able to participate in the informed consent process.	1. A subject known to have a life expectancy of \< 6 months is excluded. 2. The subject is excluded if the target ulcer is not secondary to diabetes. 3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded. 4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded. 5. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy. 6. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded. 7. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted. 8. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer. 9. 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). 10. 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. 11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. 12. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded. 13. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded. 14. A potential subject with end stage renal disease requiring dialysis is excluded. 15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days. 16. A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded. 17. A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded. 18. A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).

Inclusion Criteria

Exclusion Criteria

1. Subjects must be at least 18 years of age or older.
2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
3. 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.
4. 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.
5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
6. 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.
7. 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:
1. ABI between 0.7 and ≤ 1.3;
2. TBI ≥ 0.6;
3. TCOM ≥ 40 mmHg;
4. PVR: biphasic.
8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
10. The potential subject must consent to using the prescribed offloading method for the duration of the study.
11. The potential subject must agree to attend the weekly study visits required by the protocol.
12. The potential subject must be willing and able to participate in the informed consent process.

1. A subject known to have a life expectancy of \< 6 months is excluded.
2. The subject is excluded if the target ulcer is not secondary to diabetes.
3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
5. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
6. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
8. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
9. 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).
10. 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.
11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
12. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
13. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
14. A potential subject with end stage renal disease requiring dialysis is excluded.
15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
16. A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
17. A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.
18. A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).

Contacts and Locations

Study Contact

Jeremy J Mercuri, PhD

CONTACT

484-883-2033

jmercuri@samaritanbiologics.com

Jerry Chang, BS

CONTACT

352-256-2707

jchang@samaritanbiologics.com

Principal Investigator

Thomas E Serena, MD

PRINCIPAL_INVESTIGATOR

SerenaGroup, Inc.

Study Locations (Sites)

Monroe Biomedical Research

Monroe, North Carolina, 28112

United States

Collaborators and Investigators

Sponsor: Samaritan Biologics

Thomas E Serena, MD, PRINCIPAL_INVESTIGATOR, SerenaGroup, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-04

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Diabetic Foot Ulcer