Actively Recruiting
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
Led by Sequence LifeScience, Inc. · Updated on 2025-07-25
350
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
S
Sequence LifeScience, Inc.
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
CONDITIONS
Official Title
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old or older
- Have type 1 or type 2 diabetes mellitus
- Have a foot ulcer with a surface area between 1.0 and 15.0 cm2 measured after cleaning
- Have the ulcer present for at least 4 weeks despite standard care before screening
- Have the ulcer located on the foot with at least 50% below the ankle bone (malleolus)
- Have a Wagner grade 1 or 2 ulcer extending through the skin layers or subcutaneous tissue but not exposing tendon or bone
- Have adequate blood flow to the affected limb confirmed by tests within 3 months
- If multiple ulcers are present, they must be at least 2 cm apart; the largest qualifying ulcer will be studied
- Have the ulcer offloaded for at least 14 days before enrollment
- Agree to use the prescribed offloading method during the study
- Agree to attend weekly study visits
- Be willing and able to provide informed consent
You will not qualify if you...
- Have a life expectancy less than 6 months
- Have a foot ulcer not caused by diabetes
- Have an infected ulcer or cellulitis around the ulcer
- Have exposed tendon or bone in the ulcer
- Have osteomyelitis (bone infection) complicating the ulcer
- Be taking immunosuppressants, chemotherapy, or medications interfering with wound healing
- Have applied topical steroids to the ulcer within one month before screening
- Have foot deformities from prior amputation that prevent proper offloading
- Have glycated hemoglobin (HbA1c) level of 12% or higher within 3 months
- Have ulcer size reduced by more than 20% in the 2 weeks before screening
- Have ulcer size reduced by 25% or more during the 2-week screening phase with standard care
- Have acute or inactive Charcot foot that prevents proper offloading
- Be pregnant or planning pregnancy within 6 months
- Have end stage kidney disease requiring dialysis
- Have participated in another investigational treatment trial within 30 days
- Have medical or psychological conditions interfering with study assessments
- Have received hyperbaric oxygen therapy or similar matrix products within 30 days
- Have malnutrition
- Have allergies or sensitivities to study materials such as PBS, IPA, processing solutions, reagents, or latex
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Serena Group- Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
B
Bennett Sarver
CONTACT
T
Thomas Serena, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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