PelloGraft + SanoGraft for Foot and Leg Ulcers

Recruiting at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new treatments, PelloGraft and SanoGraft, for healing stubborn ulcers on the feet and legs. PelloGraft helps those with diabetic foot ulcers, while SanoGraft targets venous leg ulcers. The trial aims to compare these treatments to usual care, focusing on the speed and effectiveness of wound healing. People with foot or leg ulcers, especially those with diabetes or venous issues, might qualify if their wounds exceed 1 cm² and they have good blood flow to the area. As an unphased trial, this study offers a unique chance to contribute to groundbreaking research that could enhance treatment options for ulcer patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that PelloGraft is safe for humans. Research on products made from the amniotic membrane, including PelloGraft, indicates they are well-tolerated for treating diabetic foot ulcers. These studies have reported no significant severe side effects, suggesting that PelloGraft is a safe option.

Similarly, studies indicate that SanoGraft is also safe for humans. Research on amniotic membrane allografts, like SanoGraft, for venous leg ulcers has shown positive safety results. Patients did not experience major adverse events, meaning serious negative reactions were rare.

Both treatments are made from human tissue, which might explain their general tolerance. Overall, the data suggest that both PelloGraft and SanoGraft are safe for treating ulcers in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PelloGraft and SanoGraft because they offer innovative approaches to treating foot and leg ulcers. PelloGraft stands out due to its potential regenerative properties, which may help diabetic foot ulcers heal more effectively compared to traditional methods like wound dressings and debridement. SanoGraft, on the other hand, is being explored for venous leg ulcers and offers a novel application that could improve healing rates by enhancing skin regeneration. Unlike current treatments that often rely on compression therapy and topical ointments, these grafts aim to actively stimulate tissue repair, which could lead to faster recovery times and better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for foot and leg ulcers?

Research shows that PelloGraft, which uses a special layer from the human placenta, outperforms usual treatments for diabetic foot ulcers. Participants in this trial may receive PelloGraft as part of Arm 1, which focuses on diabetic foot ulcers. Studies have found it helps wounds heal faster and shrink more quickly. For SanoGraft, tested in Arm 2 for venous leg ulcers, results have been encouraging. One study found that 71% of patients using this engineered skin healed completely within six months, compared to 37% with standard care. These treatments aim to speed up healing and improve outcomes for difficult-to-heal wounds. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 have been diagnosed with diabetes.

Exclusion Criteria

Subject has an allergy to suture material

Subject is pregnant

Subject has HbA1C > 12 within 3 months Prior to randomization

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06515093

Study Assessing Complete Wound Healing by Comparing ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/f64a977ea55621ff/nct06515093-randomized-study-wound-healing-diabetic-foot-ulcers

Study Assessing Complete Wound Healing by Comparing ... The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9472416/

Human amniotic membrane products for patients with ... Many studies have shown that DHACA as a treatment for diabetic foot ulcers is more effective than standard wound care alone. For further ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06515093/study-assessing-complete-wound-healing-by-comparing-surgenexr-pellograft-in-treating-dfu-and-sanograftr-in-treating-vlu-to-soc

Study Assessing Complete Wound Healing by Comparing ... The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects.

5. clinconnect.io clinconnect.io/trials/NCT06515093

Study Assessing Complete Wound Healing by Comparing This clinical trial is designed to compare two treatments—Surgenex® PelloGraft for diabetic foot ulcers and SanoGraft® for venous leg ulcers—against standard ...

6. bu.trialstoday.org bu.trialstoday.org/trial/NCT06515093

Study Assessing Complete Wound Healing by Comparing ... The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to ...

7. researchgate.net researchgate.net/publication/397134561_Real_world_evidence_retrospective_study_to_evaluate_the_safety_and_efficacy_of_an_amniotic_membrane_allograft_for_lower_extremity_diabetic_ulcers_in_a_post-acute_care_setting

(PDF) Real world evidence retrospective study to evaluate ... Real world evidence retrospective study to evaluate the safety and efficacy of an amniotic membrane allograft for lower extremity diabetic ...