What side effects are associated with this type of intervention?

Common treatments for wound healing, such as synthetic dermal matrices, film dressings, and hydrocolloid dressings, generally have side effects that include pain at the application site, risk of infection, and drainage issues. Synthetic dressings like Suprathel are associated with less pain and fewer dressing changes but may require more caregiver intervention. Film dressings can improve pain control but often lead to higher drainage rates. Hydrocolloid dressings are linked to faster healing times but carry a risk of infection, particularly when compared to gauze dressings.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for wound healing treatments similar to SynPath™. However, it does reference the use of synthetic dermal matrices and other advanced dressings in wound care. For instance, Suprathel, an absorbent synthetic dressing, has been noted for its effectiveness in managing donor site wounds with less pain and better attachment compared to traditional dressings. Additionally, the context mentions the use of Biobrane, a biosynthetic dressing, which has been used successfully in similar applications. These treatments highlight the ongoing advancements in synthetic and biosynthetic materials for wound healing.

What other types of research exist?

Promising alternatives to SynPath™ for wound healing include: 1) Bioengineered skin substitutes like Apligraf® and Dermagraft®, which use living cells to promote healing. 2) Growth factor therapies such as platelet-derived growth factor (PDGF) and fibroblast growth factor (FGF) that enhance tissue regeneration. 3) Advanced wound dressings incorporating nanotechnology or antimicrobial agents to improve healing outcomes. 4) Extracellular matrix (ECM) products like MatriStem® that provide a scaffold for new tissue growth.

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Synthetic Dermal Matrix

SynPath for Diabetic Foot Ulcers (DFUs Trial)

N/A

Waitlist Available

Research Sponsored by PolyNovo Biomaterials Pty Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Reference ulcer has been diagnosed as either a partial or full thickness diabetic foot ulcer without tunneling, undermining, sinus tracts or /exposed bone, with a scale rating of a Wagner Grade 1 or Wagner Grade 2 extended to ligament, tendon, and joint capsule with no bone exposure

Ulcer is either located on the foot or ankle with at least 50% of ulcer below medial aspect of the malleolus

Must not have

Subject has suspected or confirmed signs/symptoms of gangrene or wound infection as evidenced by redness, pain, and purulent drainage on any part of the index limb as confirmed by X-ray or biopsy

Subject has a history of bone cancer or metastatic disease on the index limb, radiation therapy to the foot, or has had chemotherapy within twelve (12) months prior to signing informed consent form for trial participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing SynPath™, a man-made material that helps wounds heal, on patients with difficult-to-heal diabetic foot ulcers. The material acts as a support for new skin growth, making it easier for the wounds to close and heal.

Who is the study for?

Adults with Type 1 or Type 2 diabetes and chronic foot ulcers that haven't improved with previous treatments can join this trial. They must have an ulcer on the foot or ankle, be willing to use birth control if applicable, and able to follow the study's procedures including dressing changes and off-loading.

What is being tested?

The trial is testing SynPath™, a synthetic dermal matrix for diabetic foot ulcers against Standard of Care treatment which includes collagen-alginate wound dressings. Participants are randomly assigned to either receive SynPath™ or the standard treatment.

What are the potential side effects?

Potential side effects may include local reactions at the site of application like redness, pain, possible allergic reactions if sensitive to polyurethane in SynPath™, or infection signs such as increased redness and purulent drainage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diabetic foot ulcer is shallow, without deep openings or exposed bone, and is classified as Wagner Grade 1 or 2.

Select...

My ulcer is on my foot or ankle, mostly below the inner ankle bone.

Select...

My ulcer is between 1cm² and 25cm² in size after cleaning.

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My foot ulcer is at least 1cm away from any other ulcers after cleaning.

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I or my caregiver can follow the dressing change and care plan for my ulcer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have signs of infection or gangrene in a limb, confirmed by tests.

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I have had bone cancer, cancer spread to my limb, foot radiation, or chemotherapy within the last year.

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I have ulcers caused by a condition that is not diabetes.

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My wound is currently infected.

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I am currently undergoing dialysis treatment.

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I have received an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of ulcer closed at 12 weeks

Secondary study objectives

Change in reported Pain Levels between each treatment group

Comparison of closure rates for each treatment group

Cost of treatment in each treatment group

+3 more

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

Active Control

Group I: NovoSorb SynPathExperimental Treatment1 Intervention

Arm receives application on NovoSorb SynPath Dermal Matrix and appropriate Off-loading

Group II: Standard of CareActive Control1 Intervention

Arm receives application of wound dressing composed of 90% Collagen and 10% Alginate plus appropriate Off-loading

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Synthetic dermal matrices, like SynPath™, support wound healing by providing a scaffold that mimics the natural extracellular matrix. This scaffold facilitates cell migration, proliferation, and differentiation, which are essential for tissue regeneration. By promoting the formation of new tissue and blood vessels, these treatments accelerate the healing process, reduce the risk of infection, and improve overall healing outcomes for patients.