Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC

NCT06515093 | Recruiting

• 1 other identifier: 24-SUR-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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

Diabetic Foot Ulcer; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 100% epithelialization

  100% epithelialization of wound within 12 weeks (DFU) or 16 weeks (VLU) of initial treatment application. Wound closure is complete with confirmation of 100% epithelialization, no drainage, and no need for additional dressings.

  12 weeks (DFU) or 16 weeks (VLU)

Secondary Outcomes (1)

• Time to Healing

  12 weeks (DFU) or 16 weeks (VLU)

Other Outcomes (1)

• Quality of Life via subject questionnaire

  2-weeks post wound closure

Study Arms (2)

Arm 1 PelloGraft

EXPERIMENTAL

PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers

Other: PelloGraft

Arm 2 SanoGraft

EXPERIMENTAL

SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers

Other: SanoGraft

Interventions

PelloGraft OTHER

dual layer amnion/chorion-derived allograft

Arm 1 PelloGraft

SanoGraft OTHER

single layer amnion-derived allograft

Arm 2 SanoGraft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 cm2 and ≤ 50 cm2
• 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
• Subject is willing and able to comply with all protocol requirements
• Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

You may not qualify if:

• Subject is pregnant
• Subject with diagnosed diabetes 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 the wound with bacteria
• Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
• 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
• 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 study completion

Sponsors & Collaborators

• Surgenex: lead

Study Sites (2)

ILD Research

Vista, California, 92801, United States

RECRUITING

Tulsa Wound Center

Tulsa, Oklahoma, 74135, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Central Study Contacts

Pam McKeown

CONTACT

480-404-3143; pamela.mckeown@surgenex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: June 23, 2024
• Primary Completion: March 26, 2026
• Study Completion (Estimated): September 9, 2026
• Last Updated: March 3, 2026

Record last verified: 2025-08

Locations

US (2)