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PelloGraft + SanoGraft for Foot and Leg Ulcers

N/A
Recruiting
Research Sponsored by Surgenex
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 at least 18 years of age
Must not have
Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
Subject is currently undergoing cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (dfu) or 16 weeks (vlu)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare Pellograft for diabetic foot ulcers and Sanograft for venous leg ulcers to standard treatments. The study will look at wound healing outcomes like time to heal,

Who is the study for?
This trial is for individuals with diabetic foot ulcers (DFU) or venous leg ulcers (VLU). Participants should be suitable for treatment with the study products and meet specific health criteria set by the researchers. Details on who can join are not fully provided here.
What is being tested?
The trial compares two treatments: PelloGraft for DFUs and SanoGraft for VLUs, against standard wound care practices. It measures how fast wounds heal, reduction in wound size, and number of applications needed.
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions to skin grafts such as infection, pain at the site, inflammation, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood flow to my affected limb is confirmed to be adequate.
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I am 18 years old or older.
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I have been diagnosed with diabetes.
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My wound is on my foot, ankle, or leg.
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I have a diabetic foot ulcer or venous leg ulcer between 1.0 and 25 cm2, or a venous leg ulcer between 1.0 and 50 cm2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active infection or a serious wound issue.
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I am currently receiving treatment for cancer.
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I have a bone infection or exposed bones confirmed by a doctor's exam or imaging tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (dfu) or 16 weeks (vlu)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (dfu) or 16 weeks (vlu) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
100% epithelialization
Secondary study objectives
Time to Healing
Other study objectives
Quality of Life via subject questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 SanoGraftExperimental Treatment1 Intervention
SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers
Group II: Arm 1 PelloGraftExperimental Treatment1 Intervention
PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers

Find a Location

Who is running the clinical trial?

SurgenexLead Sponsor
~115 spots leftby Jun 2025
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