PelloGraft + SanoGraft for Foot and Leg Ulcers

Overseen By Pam McKeown

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Surgenex

Must not be taking: Parenteral corticosteroids, Cytotoxic agents

Disqualifiers: Pregnancy, High HbA1C, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12-16 weeks

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on parenteral corticosteroids or cytotoxic agents, you may not be eligible. Chronic oral steroid use is allowed if the dose is less than 10 mg per day of prednisone.

How is the treatment PelloGraft + SanoGraft for foot and leg ulcers different from other treatments?

PelloGraft + SanoGraft is unique because it combines two grafting techniques, potentially offering a novel approach to healing foot and leg ulcers. Unlike traditional methods that often rely on skin grafts from the patient's own body or simple dressings, this treatment may use bioengineered or donor-derived materials to promote healing. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

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)

I am 18 years old or older.

Exclusion Criteria

Subject has an allergy to suture material

Subject is pregnant

Subject has HbA1C > 12 within 3 months Prior to randomization

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PelloGraft or SanoGraft treatment for diabetic foot ulcers or venous leg ulcers, respectively, compared to standard of care

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a quality of life assessment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• PelloGraft
• SanoGraft

Trial Overview 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.

Participant Groups

Group I: Arm 2 SanoGraft Experimental Treatment 1 Intervention

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

Group II: Arm 1 PelloGraft Experimental Treatment 1 Intervention

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

PelloGraft is already approved in United States for the following indications:

Approved in United States as PelloGraft for:

• Diabetic foot ulcers
• Venous leg ulcers
• Pressure ulcers

Who Is Running the Clinical Trial?

Surgenex

Lead Sponsor

Trials

1

Recruited

180+

Findings from Research

A systematic review of nine trials involving 579 participants found that bilayer artificial skin, when used with compression bandaging, significantly increases the healing rate of venous leg ulcers compared to simple dressings.

The evidence for other types of skin grafts, such as split thickness autografts or cultured keratinocyte grafts, was inconclusive, indicating a need for further research to determine their effectiveness in treating venous ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin grafting for venous leg ulcers. Jones, JE., Nelson, EA.[2020]

For chronic leg ulcers that do not respond to standard treatments, using multiple mechanical debridements followed by split-thickness skin grafts (STSG) is a simple and safe option for effective coverage.

Combining STSG with negative pressure wound therapy (NPWT) enhances healing by promoting granulation, removing excess fluid, and improving contact pressure on the graft, leading to better surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment for chronic leg ulcer]. Drerup, C., Schlarb, D.[2020]

A meta-analysis of 11 studies involving 757 patients showed that split-thickness skin graft (STSG) effectively healed 85.5% of diabetic leg and foot ulcers within an average of 5.35 weeks, demonstrating its efficacy compared to standard care.

The STSG technique had low recurrence (4.2%) and infection rates (4.4%), with minimal donor site morbidity, suggesting it is a safe and effective treatment option for noninfected diabetic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of the Outcomes of Split-Thickness Skin Graft on Diabetic Leg and Foot Ulcers. Yammine, K., Assi, C.[2022]

In a pilot study involving 50 patients with venous leg ulcers and pressure ulcers, the innovative absorbent dressing UrgoClean significantly reduced wound surface area by an average of 23.7% for venous leg ulcers and 29.2% for pressure ulcers over a 6-week period, with full healing achieved in 6 patients.

The dressing was well-tolerated and accepted by both patients and nursing staff, showing excellent conformability and ease of use, with minimal local adverse events reported, indicating it is a promising option for managing sloughy wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic wounds with an innovative absorbent wound dressing. Meaume, S., Perez, J., Rethore, V., et al.[2012]

The review of seven randomized controlled trials found that using artificial skin in combination with compression bandaging significantly increases the healing rate of venous leg ulcers compared to compression alone.

However, there is insufficient evidence to conclude that other types of skin grafts, such as autografts or allografts, improve healing rates for venous ulcers, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin grafting for venous leg ulcers. Jones, JE., Nelson, EA.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Skin grafting for venous leg ulcers. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Surgical treatment for chronic leg ulcer]. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of the Outcomes of Split-Thickness Skin Graft on Diabetic Leg and Foot Ulcers. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Management of chronic wounds with an innovative absorbent wound dressing. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Skin grafting for venous leg ulcers. [2018]