Actively Recruiting
A Multi-Center, Randomized Clinical Investigation of Amnion/Chorion/Amnion, Amnion/Chorion, and Amnion/Amnion Allografts Versus Standard of Care in Treating Non-Healing Diabetic Foot Ulcers
Led by Tides Medical · Updated on 2025-02-10
240
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tides Medical
Lead Sponsor
P
Professional Education and Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of three types of placental tissue allografts—Amnion/Chorion/Amnion, Amnion/Chorion, and Amnion/Amnion—alongside standard wound care compared to standard care alone for treating chronic non-healing diabetic foot ulcers (DFUs). The study focuses on adults with chronic DFUs to understand whether adding these allografts improves healing after 12 weeks of treatment. Participants will receive one of several treatments: topical application of a tri-layer dehydrated amniotic membrane allograft, a tri-layer amnion/chorion allograft, a dual-layer amnion/amniotic membrane allograft, or standard wound care alone. Standard care includes calcium alginate dressings, padded multi-layer dressings, offloading boots or total contact casting, debridement, and infection management. The allografts provide a protective cover and support the body's natural healing processes and are applied directly to the ulcer without removal. During the study, participants will attend weekly visits for up to 12 weeks. Researchers will assess wound healing by measuring the percentage of ulcers healed, total time to wound closure, reduction in wound size over time, and changes in patients' reported wound pain. The study includes careful monitoring of ulcer condition and overall health to evaluate treatment safety and effectiveness over the treatment period.
CONDITIONS
Brief Title
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Presence of a diabetic foot ulcer (DFU), Wagner Grade 1, extending through the dermis and located below the medial malleolus
- The largest ulcer will be selected if multiple DFUs of the same grade exist, with other ulcers on the same foot more than 2 cm away
- Ulcer present for more than 4 weeks but less than 1 year before consent
- Ulcer size between 1.0 cm2 and 25 cm2 at screening and treatment visits
- Adequate circulation to the affected foot measured by TCOM, SPP, ABI, arterial Doppler ultrasound, or Toe Brachial Index within 3 months
- Offloading of the ulcer for at least 14 days before treatment visit
- Females of childbearing potential must use contraception and undergo pregnancy testing
- Willingness and ability to participate and comply with weekly visits
- Signed informed consent form before screening procedures
You will not qualify if you...
- Ulcer caused by a condition other than diabetes
- Ulcer suspicious for cancer or requiring biopsy
- Infected ulcer
- Recent or ongoing treatment with immune-suppressants, chemotherapy, or topical steroids near the ulcer
- Use of investigational drugs or devices within 30 days before screening
- History of radiation at the ulcer site
- Ulcer treated or needing prohibited therapies
- Previous diagnosis of HIV or Hepatitis C
- Conditions compromising ability to complete the study or poor treatment adherence
- Osteomyelitis or bone infection in the affected foot within 30 days
- Pregnant or breastfeeding
- Poor metabolic control with HbA1c over 12.0 within last 90 days
- End stage renal disease with serum creatinine ≥3.0 mg/dL within 6 months
- Acute Charcot Neuroarthropathy in the affected limb
- Ulcer area reduced by 30% or more after 14 days of standard care prior to randomization
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) for screening and enrollment
Duration - Up to 12 weeks
Participants receive topical application of placental allografts or standard of care dressings on their chronic diabetic foot ulcers to support wound healing.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 9 locations
1
Limb Preservation Platform Inc
Fresno, California, United States, 93710
Actively Recruiting
2
Angel City Research
Los Angeles, California, United States, 90010
Actively Recruiting
3
Clemente Clinical Research
Los Angeles, California, United States, 90033
Actively Recruiting
4
ILD Research Center
Vista, California, United States, 92081
Actively Recruiting
5
Clever Medical Research
Miami, Florida, United States, 33126
Actively Recruiting
6
Foot and Ankle Specialists of the Mid-Atlantic
Raleigh, North Carolina, United States, 27609
Actively Recruiting
7
Lower Extremity Institute of Research and Therapy
Boardman, Ohio, United States, 44512
Actively Recruiting
8
Brock Liden DPM
Circleville, Ohio, United States, 43113
Actively Recruiting
9
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States, 24153
Actively Recruiting
Research Team
F
Frank Burrows III, MBA, EMT, BCMAS, CWCA
M
Mora Melican, PH.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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