RECRUITING

Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs

Conditions

Diabetic Foot Ulcer Diabetic Foot Foot Ulcer Due to Type 2 Diabetes Mellitus Foot Ulcer, Diabetic Foot Ulcer Ulcer Foot

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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

This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Official Title

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers

Quick Facts

Study Start:2024-08-27

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06600724

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. At least 18 years of age or older. 2. Diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm\^2 and a maximum surface area of 5.0 cm\^2 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. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3; 2. Toe-Brachial Index (TBI) ≥ 0.6; 3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg; 4. Pulse Volume Resistance (PVR): biphasic. 8. If the potential 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. The potential subject is known to have a life expectancy of \< 6 months. 2. The potential subject's target ulcer is not secondary to diabetes. 3. The target ulcer is infected or there is cellulitis in the surrounding skin. 4. The target ulcer exposes tendon or bone. 5. There is evidence of osteomyelitis complicating the target ulcer. 6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy. 7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics). 8. The potential subject is taking hydroxyurea. 9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. 10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer. 11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. 12. 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). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable). 13. 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 visit during which time the potential subject received SOC. 14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer. 15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded. 16. The potential subject has end stage renal disease requiring dialysis. 17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days. 18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. 19. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit. 20. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment. 21. A subject has a wound with active or latent infection is excluded. 22. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded. 23. A subject with a known sensitivity to aminoglycoside antibiotics is excluded.

Inclusion Criteria

Exclusion Criteria

1. At least 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm\^2 and a maximum surface area of 5.0 cm\^2 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. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
2. Toe-Brachial Index (TBI) ≥ 0.6;
3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
4. Pulse Volume Resistance (PVR): biphasic.
8. If the potential 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. The potential subject is known to have a life expectancy of \< 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis complicating the target ulcer.
6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
8. The potential subject is taking hydroxyurea.
9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
12. 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). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
13. 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 visit during which time the potential subject received SOC.
14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
16. The potential subject has end stage renal disease requiring dialysis.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
19. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
20. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
21. A subject has a wound with active or latent infection is excluded.
22. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.
23. A subject with a known sensitivity to aminoglycoside antibiotics is excluded.

Contacts and Locations

Study Contact

Brittany Bonafide

CONTACT

888-960-1343

bbonafide@serenagroups.com

Thomas Serena, MD

CONTACT

tserena@serenagroups.com

Principal Investigator

Thomas Serena, MD

PRINCIPAL_INVESTIGATOR

SerenaGroup, Inc.

Dennis McMahon, MD

STUDY_DIRECTOR

MiMedx Group, Inc.

Study Locations (Sites)

SerenaGroup - Monroeville

Monroeville, Pennsylvania, 15146

United States

Collaborators and Investigators

Sponsor: MiMedx Group, Inc.

Thomas Serena, MD, PRINCIPAL_INVESTIGATOR, SerenaGroup, Inc.
Dennis McMahon, MD, STUDY_DIRECTOR, MiMedx Group, 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 Date2024-08-27

Study Completion Date2026-08

Study Record Updates

Study Start Date2024-08-27

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Ulcer
Foot Ulcer
Diabetic Foot Ulcer
Foot

Additional Relevant MeSH Terms

Diabetic Foot Ulcer
Diabetic Foot
Foot Ulcer Due to Type 2 Diabetes Mellitus
Foot Ulcer, Diabetic
Foot Ulcer