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Purpose

The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject is at least 18 years of age 2. Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes 3. Subject's wound is located on foot or ankle (DFU) or leg (VLU) 4. Subject has diabetic foot ulcer > 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer > 1.0 cm2 and ≤ 50 cm2 5. Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg 6. Subject is willing and able to comply with all protocol requirements 7. Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion Criteria

  1. Subject is pregnant 2. Subject with diagnosed diabetes has HbA1C > 12 within 3 months Prior to randomization 3. Subject has > 30% reduction in wound size after 2-week run-in period 4. Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria 5. Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI 6. Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose < 10 mg per day of prednisone 7. Subject is currently undergoing cancer treatment 8. Subject has used biologic skin substitutes within 14 days of enrollment 9. Subject has an allergy to suture material 10. Subject has life expectancy less than six-months as assessed by the investigator 11. Subject is participating in another clinical research study prior to this study completion

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 PelloGraft 		PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers
  • Other: PelloGraft
    dual layer amnion/chorion-derived allograft
Experimental
Arm 2 SanoGraft 		SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers
  • Other: SanoGraft
    single layer amnion-derived allograft

Recruiting Locations

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Volansky, DPM
617-414-6839
connor.roddy@bmc.org

More Details

Status
Recruiting
Sponsor
Surgenex

Study Contact

Pam McKeown
480-404-3143
pamela.mckeown@surgenex.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.