Actively Recruiting
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Led by StimLabs · Updated on 2026-03-02
272
Participants Needed
5
Research Sites
124 weeks
Total Duration
On this page
Sponsors
S
StimLabs
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
CONDITIONS
Official Title
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- Target ulcer with a surface area between 1.0 cm2 and 25.0 cm2 measured after debridement.
- Target ulcer present for 4 to 52 weeks under standard care before screening.
- Ulcer located on the foot with at least 50% below the malleolus.
- Target ulcer is full thickness without exposed bone.
- Affected limb has adequate blood flow confirmed by specified vascular tests within 3 months.
- If multiple ulcers are present, they must be at least 2 cm apart; largest ulcer meeting criteria is the target.
- Plantar ulcers must be offloaded for at least 14 days before enrollment.
- Willing to use prescribed offloading method throughout the study.
- Agree to attend weekly study visits.
- Able and willing to provide informed consent.
You will not qualify if you...
- Life expectancy less than 6 months.
- Target ulcer not caused by diabetes.
- Infected target ulcer or cellulitis in surrounding skin.
- Ulcer exposes tendon or bone.
- Evidence of osteomyelitis complicating the ulcer.
- Infection requiring systemic antibiotic therapy.
- Use of immunosuppressants or medications interfering with wound healing.
- Use of hydroxyurea.
- Topical steroids applied to ulcer within one month before screening.
- Previous partial amputation causing deformity that impedes offloading.
- Glycated hemoglobin (HbA1c) ≥ 12% within 3 months before screening.
- Target ulcer size reduced more than 20% in 2 weeks prior to screening.
- Target ulcer size decreases by 20% or more during 2-week screening phase.
- Acute or inactive Charcot foot impeding offloading.
- Pregnant women or those planning pregnancy within 6 months.
- End stage renal disease requiring dialysis.
- Participation in investigational treatment trial within 30 days.
- Medical or psychological conditions interfering with assessments.
- Target ulcer treated with hyperbaric oxygen or CAMP product within 30 days.
- Malnutrition score less than 17 on Mini Nutrition Assessment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
SerenaGroup Omaha Research Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
2
Wound Care of Tulsa
Tulsa, Oklahoma, United States, 74135
Actively Recruiting
3
SerenaGroup Research South
Jefferson Hills, Pennsylvania, United States, 15025
Not Yet Recruiting
4
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201
Not Yet Recruiting
5
SerenaGroup Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
K
Kristy Breisinger
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
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here