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

Part of paid clinical trials in Vista, California.

Sponsor
Surgenex
Study ID
NCT06515093
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PelloGraft — OTHER
    dual layer amnion/chorion-derived allograft
  • SanoGraft — OTHER
    single layer amnion-derived allograft

Study Details

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.

Key Dates

Start date
Jun 23, 2024
Status verified
Apr 2026
Primary completion
Mar 24, 2027
Completion
Sep 8, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 PelloGraft
    PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers
  • Experimental: Arm 2 SanoGraft
    SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers

Primary Outcome Measure

100% epithelialization [ Time Frame: 12 weeks (DFU) or 16 weeks (VLU) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
ILD ResearchVistaCalifornia92801
Dean Vayser, MD
[email protected]
858-337-0548
Tulsa Wound CenterTulsaOklahoma74135
Lam Le, MD
[email protected]
918-516-6661

Find similar trials in Vista, CA

By research site
ILD Research· Vista, CATulsa Wound Center· Tulsa, OK

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