Actively Recruiting
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
Led by Tides Medical · Updated on 2025-02-10
240
Participants Needed
9
Research Sites
104 weeks
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
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
CONDITIONS
Official 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
- Have a Wagner Grade 1 diabetic foot ulcer extending through the skin below the medial malleolus
- If multiple ulcers of the same grade are present, the largest ulcer will be studied; other ulcers on the same foot must be at least 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 within 3 months before screening, confirmed by specified vascular tests
- Ulcer offloaded for at least 14 days before treatment visit
- Females of childbearing potential agree to use birth control and have pregnancy tests during the study
- Willing and able to participate in weekly visits
- Signed informed consent form before screening
You will not qualify if you...
- Ulcer caused by a medical condition other than diabetes
- Ulcer suspected to be cancerous requiring biopsy
- Infected ulcer
- History of immune-suppressant treatment, chemotherapy, or topical steroids within one month before screening or anticipated during study
- Use of investigational drugs or devices within 30 days before screening
- History of radiation therapy at the ulcer site
- Ulcer previously treated or needing prohibited therapies
- Diagnosis of HIV or Hepatitis C
- Conditions that severely affect ability to complete the study or poor medical adherence history
- Osteomyelitis or bone infection in affected foot within 30 days before screening
- Pregnant or breastfeeding
- Poor diabetes control with HbA1c over 12.0 within last 90 days
- End stage renal disease with serum creatinine ≥3.0 mg/dL within 6 months before enrollment
- Acute Charcot Neuroarthropathy in affected limb
- Ulcer area reduced by 30% or more after 14 days of standard care from screening to randomization visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
Mora Melican, PH.D.
CONTACT
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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