Endoform + Symphony for Diabetic Foot Ulcers

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

50 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Endoform + Symphony for Diabetic Foot Ulcers?

The research highlights the effectiveness of similar treatments, such as a resorbable glass microfiber matrix, which significantly improved wound healing in diabetic foot ulcers compared to standard care. Additionally, a bilayer biodegradable synthetic matrix showed promise in healing and reducing amputation rates in diabetic foot ulcer patients. ^{1 2 3 4 5}

Is Endoform + Symphony safe for treating diabetic foot ulcers?

In a study using a similar treatment (resorbable glass microfiber matrix) for diabetic foot ulcers, there were no adverse events related to the treatment, suggesting it is generally safe for use in humans. ^{1 6 7 8 9}

What is the purpose of this trial?

This trial tests special wound care products on patients with hard-to-heal diabetic foot ulcers. These products help wounds heal by supporting tissue growth and preventing infections. The study aims to see if these products are safe and effective over a few months.

Research Team

David Armstrong, DPM, MD PhD

Principal Investigator

Keck School of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England 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. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Overcoming Barriers to Wound Healing in a Neuropathic and Neuro-Ischaemic Diabetic Foot Cohort Using a Novel Bilayer Biodegradable Synthetic Matrix. [2023]

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

Update of Topical Interventions for Healing Diabetic Ulcers-A Systematic Review. [2023]

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

Using a bilayer matrix wound dressing for closure of complicated diabetic foot wounds. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Complex treatment of patients with pyo-necrotic complications of the neuropathic form of diabetic foot syndrome]. [2022]

6. England 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. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Immersion of debrided diabetic foot ulcer tissue in electrochemically generated pH neutral hypochlorous acid significantly reduces the microbial bioburden: whole-genome sequencing of Staphylococcus aureus, the most prevalent species recovered. [2023]

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

Efficacy of Topical Vancomycin- and Gentamicin-Loaded Calcium Sulfate Beads or Systemic Antibiotics in Eradicating Polymicrobial Biofilms Isolated from Diabetic Foot Infections within an In Vitro Wound Model. [2021]

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

Advanced Biomaterials and Topical Medications for Treating Diabetic Foot Ulcers: A Systematic Review and Network Meta-Analysis. [2023]