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Endoform + Symphony for Diabetic Foot Ulcers

N/A

Recruiting

Research Sponsored by Aroa Biosurgery Limited

Eligibility Criteria Checklist

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

Must have

Adequate circulation to the affected foot as documented by specific measurements

At least 18 years old, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test two treatments for healing diabetic foot ulcers, evaluating their performance & safety over 12 weeks.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include skin irritation at the treatment site, allergic reactions to materials used in dressings, infection risk due to open wounds, or potential interference with wound healing.

Eligibility Criteria

Inclusion Criteria

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

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My affected foot has good blood flow.

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I am 18 years old or older.

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My ulcer is between 1.0 and 25 cm2 in size.

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I have a grade 1 or 2 diabetic foot ulcer below my inner ankle.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks

Secondary outcome measures

Change in subjects reported pain levels (NPRS)

Changes in wound quality of life (per W-QoL)

Percentage area reduction at 12 weeks

+1 more

Other outcome measures

Cost to closure

Product wastage

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with a Wagner Grade 1 or 2 diabetic foot ulcerExperimental Treatment3 Interventions

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Professional Education and Research InstituteOTHER

13 Previous Clinical Trials

1,018 Total Patients Enrolled

12 Trials studying Diabetic Foot

989 Patients Enrolled for Diabetic Foot

Aroa Biosurgery LimitedLead Sponsor

2 Previous Clinical Trials

420 Total Patients Enrolled

1 Trials studying Diabetic Foot

120 Patients Enrolled for Diabetic Foot

David Armstrong, DPM, MD PhDStudy ChairKeck School of Medicine

1 Previous Clinical Trials

120 Total Patients Enrolled

1 Trials studying Diabetic Foot

120 Patients Enrolled for Diabetic Foot

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are being monitored for this investigation?

"Affirmative, the clinical trial is seeking out new participants. According to information found on clinicaltrials.gov, this medical research project was first published in December 2021 and updated most recently in September 2023. The study requires 50 volunteers across 2 different locations."

Answered by AI

Has recruitment for this research project begun?

"Affirmative. According to clinicaltrials.gov, this healthcare study is currently recruiting participants after having gone online on December 29th 2021 and being updated as recently as September 13th 2023. A total of 50 patients need to be enrolled at 2 distinct sites in order for the trial to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™

2021. "Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06035523.