Study Assessing Complete Wound Healing by Comparing Surge... | NCT06515093

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

NCT06515093

Sponsor

Surgenex

Status

Recruiting

Last Update Posted

Apr 7, 2026Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Diabetic Foot Ulcer
Venous Leg Ulcer

Interventions

PelloGraft
SanoGraft

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2024Actual

Primary Completion Date

Mar 24, 2027Estimated

Completion Date

Sep 8, 2027Estimated

First Submitted Date

Jul 17, 2024

First Submission Date that Met QC Criteria

Jul 17, 2024

First Posted Date

Jul 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2026

Last Update Posted Date

Apr 7, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PelloGraft	Other	dual layer amnion/chorion-derived allograft	Arm 1 PelloGraft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Time to Healing	Time to Healing (from initial application of study product to 100% epithelialization of wound)	12 weeks (DFU) or 16 weeks (VLU)

Other Outcomes

Measure	Description	Time Frame
Quality of Life via subject questionnaire	Qualify of Life at 2-week post closure follow-up via SF-36 Questionnaire	2-weeks post wound closure

Eligibility Module

Eligibility Criteria

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 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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017719	Diabetic Foot
D014647	Varicose Ulcer

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer