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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
Must not have
Index ulcer is overtly infected
Index ulcer has been previously treated or will need to be treated with any prohibited therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
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.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My wound is clearly infected.
Select...
My ulcer has not been treated with any therapies that are not allowed in this study.
Select...
I have Charcot foot affecting one of my limbs.
Select...
I have received radiation therapy at the site of my ulcer.
Select...
My kidney function is severely impaired with high creatinine levels.
Select...
My diabetes is not well-controlled, with an HbA1c over 12.0 in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks
Secondary study objectives
Change in subjects reported pain levels (NPRS)
Changes in wound quality of life (per W-QoL)
Percentage area reduction at 12 weeks
+1 moreOther study objectives
Cost to closure
Product wastage
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Professional Education and Research InstituteOTHER
15 Previous Clinical Trials
1,360 Total Patients Enrolled
14 Trials studying Foot Ulcer
1,331 Patients Enrolled for Foot Ulcer
Aroa Biosurgery LimitedLead Sponsor
2 Previous Clinical Trials
920 Total Patients Enrolled
1 Trials studying Foot Ulcer
120 Patients Enrolled for Foot Ulcer
David Armstrong, DPM, MD PhDStudy ChairKeck School of Medicine
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Foot Ulcer
120 Patients Enrolled for Foot Ulcer