RecruitingNot ApplicableNCT06674980

Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

Sponsor

C5 Biomedical

Enrollment

177 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus, Type 2 Pathologic Processes Vascular Diseases Skin Diseases Diabetic Foot Foot Ulcer Diabetic Neuropathies Diabetes Complications Glucose Metabolism Disorders Metabolic Diseases Endocrine System Disease Diabetic Angiopathies Leg Ulcer Skin Ulcer Foot Diseases Ulcer Foot Ulcer Unhealed

Summary

The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Eligibility

Min Age: 18 Years

Inclusion Criteria21

At least 18 years of age or older.
Must have diagnosis of type 1 or 2 Diabetes mellitus.
At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.
Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.
Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
Target ulcer that is 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.
Subject's 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
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.
At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 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.
No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
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.

Exclusion Criteria43

Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.
Subject must consent to using the prescribed offloading method for the duration of the study.
Subject must agree to attend weekly study visits.
Subject must be willing and able to participate in the consent process.
Subject is known to have a life expectancy of \< 6 months.
Subject's target ulcer is not secondary to diabetes.
Target ulcer is infected or there is cellulitis in the surrounding skin.
Target ulcer exposes tendon or bone.
Evidence of osteomyelitis complicating the target ulcer.
Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
The 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).
Subject is taking hydroxyurea.
Subject has applied topical steroids to the ulcer surface within one month of initial screening.
Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
The surface area of the subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). 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).
The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.
Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.
Subject has end stage renal disease requiring dialysis.
Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.
Subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
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.
The potential subject is known to have a life expectancy of \< 6 months.
The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
The target ulcer exposes tendon or bone.
There is evidence of osteomyelitis complicating the target ulcer.
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).
The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
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). 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).
The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
Women who are pregnant or considering becoming pregnant within the next 6 months.
The potential subject has end stage renal disease requiring dialysis.
Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
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.
The subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
A subject has a wound with active or latent infection is excluded.
A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.

Interventions

OTHERStandard of Care - DFU

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHERAM/Single - DFU

Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHERAM/Double - DFU

Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHERStandard of Care - VLU

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHERAM/Single - VLU

Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHERAM/Double - VLU

Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.