Phase
Condition
Pressure Ulcer
Ulcers
Diabetes Mellitus, Type 2
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
Diabetic Foot Ulcer Only - 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 with diagnosed diabetes has HbA1C > 12 within 3 months Prior torandomization
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 joint capsule on investigator's exam or radiographicevidence or bone culture, histology, x-ray changes 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 StatesSite Not Available
ILD Research
Vista 5406602, California 5332921 92801
United StatesActive - Recruiting
Future Life Clinical Trials
North Miami 4166232, Florida 4155751 33169
United StatesActive - Recruiting
Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
United StatesActive - Recruiting
Essential Medical Research
Tulsa 4553433, Oklahoma 4544379 74137
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.