Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06674980

Study Comparing Human Placental Membrane Products Plus Standard Care Versus Standard Care Alone for Nonhealing Diabetic Foot and Venous Leg Ulcers Using a Randomized Controlled Platform Trial Design

Led by C5 Biomedical · Updated on 2024-12-27

177

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

Sponsors

C

C5 Biomedical

Lead Sponsor

S

SerenaGroup, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of multiple human placental membrane products combined with standard care compared to standard care alone for treating nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This multicenter, prospective, randomized controlled trial uses a modified platform design to study different cellular, acellular, and matrix-like products (CAMPs) in subjects who meet specific medical criteria. The trial aims to understand how these products aid in ulcer closure over a 12-week period. Participants receive weekly treatments starting at the screening visit. Depending on their assigned group, they will either receive standard care alone or standard care plus weekly applications of one of two placental membrane products, AM/Single or AM/Double. Standard care includes cleaning, debridement, moisture balance, offloading for DFUs, or compression for VLUs. Treatments continue until the ulcer closes or until 12 weeks have passed. During the study, participants attend weekly visits for treatment and monitoring. Researchers assess ulcer closure rates, measuring the percentage of subjects whose target ulcers fully close within 12 weeks. Assessments include imaging and vascular evaluations to confirm adequate blood flow. Safety and healing progress are closely monitored to evaluate the clinical utility of the placental membrane products compared to standard care alone.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Diagnosed with type 1 or type 2 diabetes (for diabetic foot ulcer group)
  • Have a target ulcer between 0.7 cm2 and 20 cm2 after cleaning and debridement
  • Ulcer present for at least 4 weeks and no more than 52 weeks of prior standard care
  • Target ulcer located on the foot with at least 50% below the malleolus (for diabetic foot ulcers)
  • Ulcer classified as Wagner grade 1 or 2 without exposed tendon or bone
  • Adequate blood flow to the affected limb confirmed by vascular tests within 3 months
  • If multiple ulcers, at least 2 cm apart; largest ulcer chosen as target
  • Ulcer on the bottom of the foot and offloaded for at least 14 days before enrollment
  • Agree to use prescribed offloading method throughout the study
  • Agree to attend weekly study visits
  • Willing and able to provide informed consent (for venous leg ulcers, similar criteria apply with focus on ulcer size, duration, healing signs, and perfusion)
Not Eligible

You will not qualify if you...

  • Life expectancy less than 6 months
  • Ulcer not caused by diabetes (for diabetic foot ulcers)
  • Infected ulcer or cellulitis around the ulcer
  • Ulcer exposing tendon or bone
  • Evidence of bone infection (osteomyelitis) in the ulcer area
  • Currently taking immunosuppressants, cytotoxic chemotherapy, or certain medications affecting wound healing
  • Using hydroxyurea
  • Applied topical steroids to the ulcer within one month before screening
  • Previous foot amputation causing deformity affecting ulcer offloading
  • HbA1c level 12% or higher within 3 months before screening
  • Ulcer size reduced by more than 20% in the 2 weeks before screening or during the 2-week screening phase
  • Acute or inactive Charcot foot affecting ulcer offloading
  • Pregnant or planning pregnancy within 6 months
  • End-stage kidney disease requiring dialysis
  • Participated in another investigational treatment trial within 30 days
  • Medical or psychological condition interfering with study assessments
  • Received hyperbaric oxygen therapy or CAMP treatment within 30 days
  • Malnutrition score below 17 on Mini Nutritional Assessment
  • Wound with active or latent infection (for venous leg ulcers)
  • Conditions causing unacceptable risk of surgical complications (for venous leg ulcers)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Poirot Podiatry

Metairie, Louisiana, United States, 70001

Actively Recruiting

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Research Team

B

Bennett Rogers

C

Connie Chung, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

Frequently Asked Questions

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Study Comparing Human Placental Membrane Products Plus Standard Care Versus Standard Care Alone for Nonhealing Diabetic Foot and Venous Leg Ulcers Using a Randomized Controlled Platform Trial Design | DecenTrialz