Actively Recruiting
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Led by Applied Biologics, LLC · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Applied Biologics, LLC
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a single layer placental-based allograft combined with standard care for treating nonhealing diabetic foot ulcers. This controlled clinical trial follows a rescue design where patients who do not heal during a previous trial (CAMPX) and were treated only with standard care can enroll to receive the new study product. Participants must meet specific medical criteria related to cellular and matrix-like products as defined by Medicare guidelines. The intervention involves applying the single-layer amniotic membrane product called XWRAP alongside standard care for up to 12 weeks. Patients entering this rescue trial previously failed to heal their ulcers under standard care alone in the CAMPX trial. This study evaluates wound closure and related healing outcomes over this 12-week period. Participants will attend weekly study visits for up to 12 weeks during which researchers will assess wound closure, time to closure, wound size reduction, adverse events, and quality of life related to the wound. Several scales measuring wound impact and pain will also be used. Safety and wound healing progress will be closely monitored throughout the study duration.
CONDITIONS
Brief Title
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older.
- Diagnosed with type 1 or type 2 diabetes mellitus.
- If multiple ulcers exist, the target ulcer must be the same one treated in the CAMPX study.
- Must agree to use the prescribed offloading method during the study.
- Must agree to attend weekly study visits as required by the protocol.
- Must be willing and able to participate in the informed consent process.
- Must have participated in the CAMPX trial in the standard of care only arm and not achieved complete closure by 12 weeks.
You will not qualify if you...
- Life expectancy less than 6 months.
- Target ulcer not caused by diabetes.
- Target ulcer is infected or surrounded by cellulitis.
- Target ulcer exposes tendon or bone.
- Evidence of osteomyelitis in the target ulcer.
- Infection requiring systemic antibiotics either in the ulcer or elsewhere.
- Receiving immunosuppressants or chemotherapy drugs that interfere with wound healing.
- Used topical steroids on the ulcer within one month before screening.
- Previous partial amputation causing deformity that impedes offloading.
- Glycated hemoglobin (HbA1c) of 12% or higher within 3 months before screening.
- Acute or inactive Charcot foot impeding proper offloading.
- Pregnant or planning pregnancy within 6 months.
- End stage renal disease requiring dialysis.
- Medical or psychological conditions that interfere with study assessments.
- Malnutrition indicator score less than 17.
- Did not participate in the CAMPX trial or were not in the standard care only arm.
- Achieved complete ulcer closure in the CAMPX trial.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive application of XWRAP plus standard of care for their diabetic foot ulcers.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Royal Research
Hollywood, Florida, United States, 33024
Actively Recruiting
Research Team
B
Bennett Sarver
T
Thomas Serena, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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