PEP-TISSEEL for Diabetic Foot Ulcers

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Rion Inc.

Must not be taking: Antibiotics, Immunosuppressants, Corticosteroids

Disqualifiers: Chemotherapy, Charcot foot, HIV, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a special glue-like substance called PEP-TISSEEL combined with usual treatments on patients with non-healing diabetic foot ulcers. The goal is to see if this combination helps wounds heal better by sticking tissues together and promoting faster healing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on or require antibiotics, or if you are taking immunosuppressive agents, except for stable low doses of corticosteroids. It's best to discuss your specific medications with the trial team.

How is the PEP-TISSEEL treatment different from other treatments for diabetic foot ulcers?

PEP-TISSEEL is unique because it is a fibrin sealant, which means it uses proteins to help blood clot and seal wounds, potentially speeding up the healing process. This is different from other treatments like antibiotics or dressings, which focus on infection control or wound coverage. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with diabetic foot ulcers. Specific criteria aren't provided, but typically participants would need to have a confirmed diagnosis of DFU and be in stable health otherwise.

Inclusion Criteria

Must meet one of the following criteria:

- Dorsal transcutaneous oxygen measurement (TCOM/TcPO2) measurement of ≥ 40 mmHg within 90 days of Screening (Visit 1 or 2)

My wound is between 1 cm2 and 15 cm2 after cleaning.

Exclusion Criteria

I cannot or will not use the specified support device.

I have an active case of Charcot foot.

I had surgery to improve blood flow in my limb within the last 30 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive PEP-TISSEEL+SOC or SOC only treatment for diabetic foot ulcers

12 weeks

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• PEP-TISSEEL (Biological)

Trial Overview The study is testing PEP-TISSEEL, applied topically on diabetic foot ulcers. It's designed to see if this treatment is safe and works well (efficacy) compared to other treatments or placebos.

Participant Groups

Group I: PEP-TISSEEL+SOC Active Control 1 Intervention

Treatment for the PEP-TISSEEL+SOC arm is: * PEP-TISSEEL * Mepitel dressing followed by Tegaderm® (Mepilex can be used if subjects are allergic to Tegaderm) * 3M Cavilon® (may be used on the borders prior to placing the Tegaderm or Mepilex) * Padded 3-layer secondary outer layer dressing (Profore (Smith and Nephew (Memphis, TN)); and * Offloaded with an offloading Controlled Ankle Movement (CAM) Boot (Foot Defender (Miami, FL) or Total Contact Cast (TCC)) Use of an alternate offloading device (e.g., Charcot Restraint Orthotic Walker (CROW) boot, custom shoe, etc.) may be approved on a case-by-case basis

Group II: Standard of Care Placebo Group 1 Intervention

* Fibracol * Mepitel dressing followed by Tegaderm (Mepilex can be used if subjects are allergic to Tegaderm) * 3M Cavilon (may be used on the borders prior to placing the Tegaderm or Mepilex ) * Padded 3-layer secondary outer layer dressing (Profore (Smith and Nephew (Memphis, TN)) or equivalent); and * Offloaded with an offloading CAM Boot (Foot Defender (Miami, FL) or TCC) * Use of an alternate offloading device (e.g., Charcot Restraint Orthotic Walker (CROW) boot, custom shoe, etc.) may be approved on a case-by-case basis

PEP-TISSEEL is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as TISSEEL for:

• Hemostasis
• Sealing of colonic anastomoses following reversal of temporary colostomies

🇪🇺 Approved in European Union as TISSEEL for:

• Hemostasis
• Sealing of colonic anastomoses following reversal of temporary colostomies

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Professional Education & Research Institute (PERI) Blue Ash, OH

Who Is Running the Clinical Trial?

Rion Inc. Lead Sponsor

Professional Education and Research Institute Collaborator

References

1. France pubmed.ncbi.nlm.nih.gov

[Local care and medical treatment for ischemic diabetic ulcers]. [2022] Optimal medical treatment of ischemic diabetic ulcers is multifactorial. Infection is very common and it is necessary to distinguish between limb or life threatening infections and non-limb-threatening infections. The major pathogen associated with non-limb-threatening infection is staphylococcus aureus; oral antibiotics such as amoxicillin/clavulanate or clindamycin can be used. For severe infection, empiric antibiotic therapy is broader-spectrum covering staphylococci, streptococci, gram-negative bacilli and enterococci; intravenous administration is the rule. Duration of antibiotic therapy depends on severity and depth of infection, and on requirement of surgical debridment. Granulocyte colony-stimulating factor is a growth factor stimulating proliferation and function of neutrophils. As an adjunctive therapy for limb-threatening infections, it is associated with a lower rate of amputation. Increasing arterial perfusion if the patient is unsuitable for reconstructive surgery or angioplasty is desirable. Iloprost is an analogue of epoprostenol with effects on platelet aggregability and vasodilatation. It improves ulcer healing, decreases pain, slightly diminishes the rate of amputation. Systemic hyperbaric oxygen therapy can perhaps improve clinical outcome but additional research is needed to define the specific indications and benefits of this treatment modality. Local care is not rationalized and depends on local habits. Debridment is required. Non necrotic wounds can be covered by modern dressing (hydrophilic dressing, alginates, hydrocolloid). Necrotic wounds are dryed until surgical revascularization, or excised if they are limited and superficial. Pinch grafts are very useful for arterial ulcers. The place of topical growth factor like PDGF (platelet derived growth factor) and of living skin equivalents (dermagraft, apligraf) is not defined in ischaemic diabetic ulcers. Treatment of edema is necessary, because it retards or complicates healing. Inelastic bandages can be useful with good tolerance if ischemia is not critical. Pneumatic foot compression is under evaluation. Electric stimulation could be an adjuncting treatment, but with a problem of compliance. Reducing plantar pressure is always necessary.

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

NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers. [2019] Significance: Diabetes is a disorder that is well known to delay wound repair resulting in the formation of colonized chronic wounds. Over their lifetime, diabetic patients have a 25% incidence of foot ulcers (DFUs), which contribute to increased risk of morbidity, including osteomyelitis and amputations, and increased burden to the healthcare system. Recent Advances: The only active product approved for the treatment of diabetic ulcers, Regranex®, is not widely used due to minimal proven efficacy and recent warnings added to the Instructions for Use. A novel topical agent that accelerates healing and increases the proportion of fully healed DFUs, DSC127 [aclerastide; active ingredient, NorLeu3-angiotensin (1-7) (NorLeu3-A(1-7))], is recruiting patients in Phase III clinical trials (NCT01830348 and NCT01849965). NorLeu3-A(1-7) is an analog of the naturally occurring peptide, angiotensin 1-7. The mechanisms of action include induction of progenitor proliferation, accelerated vascularization, collagen deposition, and re-epithelialization. Critical Issues: Current modalities for the treatment of DFUs include strict offloading, bandaging, debridement and, on a limited basis, application of Regranex. Novel potent therapies are needed to combat this significant burden to the diabetic patient and the healthcare system. Future Direction: Preclinical and clinical research shows that DSC127 is highly effective in the closure of diabetic wounds and is superior to Regranex in animal studies. Clinical development of DSC127 as a topical agent for the healing of DFU is underway. Further investigation into the mechanisms by which this product accelerates healing is warranted.

3. Germany pubmed.ncbi.nlm.nih.gov

Treatment of diabetic foot ulcers using Mepilex Lite Dressings: a pilot study. [2014] 5-10% diabetes patients will develop diabetic foot ulceration at some time during the life. The purpose of this study was to compare the effectiveness of Mepilex Lite dressings and vaseline gauze care in the healing of foot ulcers in diabetic patients.

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

A systematic review and meta-analysis of adjunctive therapies in diabetic foot ulcers. [2022] Multiple adjunctive therapies have been proposed to accelerate wound healing in patients with diabetes and foot ulcers. The aim of this systematic review is to summarize the best available evidence supporting the use of hyperbaric oxygen therapy (HBOT), arterial pump devices, and pharmacologic agents (pentoxifylline, cilostazol, and iloprost) in this setting.

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

Uso de apósitos con TLC-NOSF en el manejo de la úlcera de pie diabético, basado en la revisión de la evidencia y la práctica clínica. [2021] Management of diabetic foot ulcers with a TLC-NOSF dressing, based on evidence and clinical practice The incidence of diabetic foot ulcers (DFU) has increased in the past decade, both in Chile and worldwide, as a result of the progressive growth in diabetes prevalence. Because DFU are associated with a high risk of infection and amputation, it is crucial to choose effective and evidence-based treatments. A dressing combining technology lipidocolloid with nano-oligo saccharide factor (TLC-NOSF) has demonstrated its effectiveness in managing DFU. This article reviews the evidence around TLC-NOSF and its implementation in clinical practice.