Endoform + Symphony for Diabetic Foot Ulcers

No longer recruiting at 3 trial locations

Overseen By Frances Parker, DMP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aroa Biosurgery Limited

Must not be taking: Immune-suppressants, Chemotherapy, Steroids, others

Disqualifiers: Cancer, HIV, Hepatitis C, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a combination of treatments—Endoform™ Natural, Endoform™ Antimicrobial, and Symphony™—for diabetic foot ulcers that do not heal on their own. The goal is to assess how well these treatments improve ulcers after 12 weeks. The trial seeks individuals with a diabetic foot ulcer lasting more than four weeks but less than a year, specifically those with a Wagner Grade 1 or 2 ulcer. Participants must attend weekly visits and have an ulcer that is neither infected nor caused by a condition other than diabetes.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how these treatments can benefit patients with diabetic foot ulcers.

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 immune-suppressants, systemic corticosteroids over 10mg daily, cytotoxic chemotherapy, or topical steroids on the ulcer, you may not be eligible to participate.

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

Research has shown that treatments using Endoform™ and Symphony™ are generally well-tolerated. One study involving a similar treatment (a dissolvable glass microfiber material) for diabetic foot ulcers found no negative effects linked to the treatment. This suggests that Endoform™ Natural, Endoform™ Antimicrobial, and Symphony™ are likely safe for most people. Additionally, Endoform™ has been shown to help wounds heal faster than some other treatments. While this is encouraging, consider personal health conditions and consult a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard care for diabetic foot ulcers, which often involves topical treatments, wound dressings, and debridement, the combination of Endoform™ Antibacterial, Endoform™ Natural, and Symphony™ stands out because of its unique blend of advanced wound care technologies. Endoform™ products are derived from ovine forestomach and are known for their natural extracellular matrix, which supports tissue regeneration. Symphony™ is a novel addition that enhances the wound healing process by providing a conducive environment for skin cell growth. This combination not only targets bacterial infection but also actively promotes tissue repair, offering a promising new approach to managing diabetic foot ulcers.

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

Research has shown that using Endoform™ and Symphony™ together can effectively treat diabetic foot ulcers. One study found that ulcers treated with Endoform healed up to 5.6 weeks faster, increasing recovery chances. Another study demonstrated a significant decrease in wound size and depth, indicating improved wound care. In this trial, participants with Wagner Grade 1 or 2 diabetic foot ulcers will receive treatment with Endoform™ Natural, Endoform™ Antibacterial, and Symphony™ to enhance healing for chronic diabetic foot ulcers. ^{1 2 3 6 7}

Who Is on the Research Team?

David Armstrong, DPM, MD PhD

Principal Investigator

Keck School of Medicine

Are You a Good Fit for This Trial?

Adults with chronic diabetic foot ulcers present for 4 weeks to less than a year, sized 1-25 cm2. They must have good blood flow to the foot and have offloaded the ulcer for at least two weeks. Women who can bear children should use birth control and not be pregnant or breastfeeding. Excluded are those with certain medical conditions, previous treatments, poor diabetes control (HbA1c >12), or severe kidney disease.

Inclusion Criteria

Subject understands and is willing to participate in the clinical study and can comply with weekly visits

Subjects must have read and signed the IRB approved ICF before screening procedures are performed

My ulcer has been present for more than 4 weeks but less than a year.

Exclusion Criteria

My wound is clearly infected.

I have not had specific treatments recently.

My foot has a bone infection confirmed by an x-ray in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly treatment and evaluations with Endoform™ and Symphony™ for diabetic foot ulcers

12 weeks

Weekly visits (in-person)

Follow-up

Participants who heal enter a follow-up period to confirm healing

2 weeks

1 visit (in-person)

End of Study

Participants who do not heal exit the study at Week 13

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endoform™ Antibacterial
• Endoform™ Natural
• Symphony™

Trial Overview The study tests Endoform™ Natural and Endoform™ Antimicrobial dressings combined with Symphony™ on healing diabetic foot ulcers over 12 weeks. It assesses how well these products work together in wound closure compared to other treatments.

How Is the Trial Designed?

Group I: Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer Experimental Treatment 3 Interventions

Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading

Who Is Running the Clinical Trial?

Aroa Biosurgery Limited

Lead Sponsor

Trials

3

Recruited

970+

Professional Education and Research Institute

Collaborator

Trials

16

Recruited

1,400+

Published Research Related to This Trial

The Exufiber dressing significantly improved the condition of peri-wound skin in patients with diabetic foot ulcers, with the number of patients having healthy skin increasing from 28.6% to 66.7% over 12 weeks.

There was a statistically significant reduction in wound area and volume, indicating effective management of exuding wounds, while the dressing was safe with no reported adverse events related to its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open, non-comparative, multi-centre post clinical study of the performance and safety of a gelling fibre wound dressing on diabetic foot ulcers. Chadwick, P., McCardle, J.[2016]

In a randomized controlled trial involving 40 participants, the resorbable glass microfiber matrix (BBGFM) significantly improved healing rates of diabetic foot ulcers (DFUs) at 12 weeks, with 70% of wounds healed compared to only 25% in the standard of care group.

The BBGFM group also showed a greater reduction in wound area (79% vs. 37%) and improved neuropathic scores, indicating better overall outcomes without any adverse events related to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers. Armstrong, DG., Orgill, DP., Galiano, RD., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06035523?term=AREA%5BConditionSearch%5D(%22Diabetic%20Angiopathy%22)%20AND%20AREA%5BInterventionSearch%5D(%22anti-infective%20agents%22)&rank=6

Clinical Study Evaluating Wound Closure With Endoform™ ... The purpose of this study is to evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ (together, ...

2. aroa.com aroa.com/wp-content/uploads/2023/07/Endoform-Real-world-Data-Analysis.pdf

Endoform-Real-world-Data-Analysis. ... In fact,. DFUs closed up to 5.6 weeks (21.4%) faster with Endoform. Results: Probability of DFU Closure: The probability of DFU closure increased by up to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9013592/

Retrospective real‐world comparative effectiveness of ovine ... The retrospective pragmatic real‐world data (RWD) study compared the healing outcomes of diabetic foot ulcers (DFUs) treated with either ovine ...

4. finance.yahoo.com finance.yahoo.com/news/aroa-hits-evidence-milestone-real-024200301.html

AROA hits evidence milestone with real-world study ... AROA hits evidence milestone with real-world study validating the efficacy of Endoform in treating challenging venous leg ulcers. Oops, ...

5. withpower.com withpower.com/trial/phase-diabetic-foot-11-2021-9fcfa

Endoform + Symphony for Diabetic Foot Ulcers There was a statistically significant reduction in wound area and volume, indicating effective management of exuding wounds, while the dressing was safe with no ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06035523/clinical-study-evaluating-wound-closure-with-endoformtm-and-symphonytm?state=FL&city=Chula%20Vista

Clinical Study Evaluating Wound Closure With Endoform ... Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932735/

Updates on Recent Clinical Assessment of Commercial ... A current trial is underway to examine the safety and efficacy of Matrion™ in managing diabetic foot ulcers and lower extremity wounds. The trial involves 120 ...