Phase
Condition
Diabetes And Hypertension
Venous Leg Ulcers
Pressure Ulcer
Treatment
SanoGraft
PelloGraft
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is at least 18 years of age
Subject has diagnosed Type 1 or Type 2 diabetes
Subject's wound is located on foot or ankle (DFU) or leg (VLU)
Subject has diabetic foot ulcer > 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer > 1.0 cm2and ≤ 50 cm2
Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mmHg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great ToePressure ≥ 50 mmHg
Subject is willing and able to comply with all protocol requirements
Subject is willing and able to provide informed consent or obtain consent from legalauthorized representative (LAR)
Exclusion
Exclusion Criteria:
Subject is pregnant
Subject has HbA1C > 12 within 3 months Prior to randomization
Subject has > 30% reduction in wound size after 2-week run-in period
Subject has active infection, undrained abscess, or critical colonization of thewound with bacteria
Subject has osteomyelitis or exposed bones, probes to bone or joint capsule oninvestigator's exam or radiographic evidence or bone culture, histology, x-raychanges or MRI
Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutivedays during 30 days before screening. Chronic oral steroid use is not excluded ifdose < 10 mg per day of prednisone
Subject is currently undergoing cancer treatment
Subject has used biologic skin substitutes within 14 days of enrollment
Subject has an allergy to suture material
Subject has life expectancy less than six-months as assessed by the investigator
Subject is participating in another clinical research study prior to this studycompletion
Study Design
Connect with a study center
ILD Research
Vista, California 92801
United StatesActive - Recruiting
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