Actively Recruiting
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
Led by ConvaTec Inc. · Updated on 2025-05-21
194
Participants Needed
9
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
CONDITIONS
Official Title
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged at least 21 years, with at least 50% of participants over 65 years old
- Known history of type 1 or type 2 diabetes
- Diabetic foot ulcer that is Wagner Grade 1 or 2
- Ulcer located on the foot, with at least 50% of the ulcer area distal to the medial malleolus
- Ulcer present for at least 4 weeks and no longer than 52 weeks
- Ulcer showing less than 50% wound area reduction over the 4 weeks before randomization
- Ulcer surface area between 1.0 and 25.0 cm2 measured after debridement
- If multiple ulcers of the same grade exist, the index ulcer must be largest, at least 2 cm from others, and the only ulcer studied
- Adequate blood circulation in the affected limb as shown by recent ABI, TBI, TCOM, or PVR measures
- Body mass index (BMI) of 45 or less
- Willingness to participate in all study procedures and follow-ups
- Signed informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer caused by conditions other than diabetes
- Active Charcot deformity or major foot structural abnormalities
- Known or suspected local skin cancer at the ulcer site
- Ulcer duration longer than 12 months without intermittent closure
- Ulcer showing two or more signs of clinical infection (erythema, warmth, purulent exudate, swelling, tenderness)
- Presence of osteomyelitis or exposed bone or joint capsule
- Use of immunosuppressants, radiation therapy, cytotoxic chemotherapy, or other medications interfering with healing
- Topical steroid use on ulcer within one month before screening
- HbA1c of 12% or higher within 3 months before screening
- Ulcer area decreased by more than 25% during the 2 weeks before screening or during the 2-week screening phase
- Inability to follow offloading requirements if needed
- Pregnancy or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in another investigational treatment trial within 30 days
- Medical or psychological conditions interfering with study assessments
- Hyperbaric oxygen therapy or matrix product treatment within 30 days before screening
- Malnutrition score less than 17 on Mini Nutritional Assessment
- Allergy or sensitivity to porcine materials or collagen
- Religious or personal objection to porcine or animal-derived materials
- Disorders that increase risk of treatment complications
- Immune disorders including SLE, AIDS, or HIV
- Revascularization or amputation of target limb within past 6 months
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Angel City Research
Los Angeles, California, United States, 90010
Actively Recruiting
2
Center for Clinical Research
San Francisco, California, United States, 94115
Actively Recruiting
3
ILD Research Center
Vista, California, United States, 92081
Actively Recruiting
4
Dinamo Research and Diagnostic Center
Hialeah, Florida, United States, 33015
Not Yet Recruiting
5
Indiana Foot & Ankle
Jasper, Indiana, United States, 47456
Actively Recruiting
6
US-FAS
Hagerstown, Maryland, United States, 21742
Actively Recruiting
7
Boston Medical Center
Boston, Massachusetts, United States, 02118
Not Yet Recruiting
8
Northwell Health Comprehensive Wound Healing Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
9
US-FAS
Raleigh, North Carolina, United States, 27609
Actively Recruiting
Research Team
A
Andrew Thomas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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