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Procedure

Symphony™ Treatment 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
At least 18 years old, inclusive
Presence of a DFU, Wagner Grade 1 or 2 (see Appendix B for definitions), extending through the dermis provided it is below the medial aspect of the malleolus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will compare a new wound-care treatment to the established standard in treating chronic diabetic foot ulcers.

Who is the study for?
Adults with chronic non-healing diabetic foot ulcers present for more than 4 weeks but less than a year, who have offloaded the ulcer for at least 14 days and have adequate circulation to the affected foot. They must understand and comply with study requirements, including weekly visits, and use contraception if of childbearing potential. Exclusions include pregnancy, breastfeeding, suspected cancerous ulcers, overt infection or recent immune-suppressant use.Check my eligibility
What is being tested?
The trial is testing Symphony™ combined with off-loading against standard wound dressing (calcium alginate Fibracol) in healing diabetic foot ulcers over a period of 12 weeks. The goal is to assess which treatment is safer and more effective in managing these chronic wounds.See study design
What are the potential side effects?
While specific side effects are not listed here, generally treatments like Symphony™ may cause skin irritation or allergic reactions at the application site. Standard care dressings could also lead to similar local reactions or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have a diabetic foot ulcer below my ankle.
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My largest foot ulcer will be the one studied, and any other ulcers are at least 2 cm away from it.
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My ulcer is between 1.0 and 25 cm2 in size.

Timeline

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 healed at 12 weeks
Secondary outcome measures
Change in pain levels during the clinical investigation
Changes in wound quality of life (per W-QoL)
Percentage area reduction at 12 weeks
+1 more
Other outcome measures
Cost to closure (both treatment groups; all wounds, and only closed wounds)
Product wastage (Symphony only)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Symphony™ treatmentExperimental Treatment1 Intervention
Arm receives an application of Symphony™ treatment and appropriate Off-loading.
Group II: Standard of Care (SOC) treatmentActive Control1 Intervention
Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.

Find a Location

Who is running the clinical trial?

Aroa Biosurgery LimitedLead Sponsor
2 Previous Clinical Trials
350 Total Patients Enrolled
1 Trials studying Foot Ulcer
50 Patients Enrolled for Foot Ulcer
Professional Education and Research InstituteOTHER
13 Previous Clinical Trials
948 Total Patients Enrolled
12 Trials studying Foot Ulcer
919 Patients Enrolled for Foot Ulcer
David Armstrong, DPM, MD PhDStudy ChairKeck School of Medicine
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Foot Ulcer
50 Patients Enrolled for Foot Ulcer

Frequently Asked Questions

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

Has recruitment begun for the trial participants?

"According to the authoritative source clinicaltrials.gov this research endeavour is currently recruiting for participants, with the initial posting on June 8th 2023 and a subsequent update occurring September 13th 2023."

Answered by AI

In which areas can this research be accessed?

"Bay Area Foot Care, Doctor's Research Network, and Barry University Clinical Research are all providing clinical trial services for this medication in San Francisco, Florida, North carolina and Tamarac Ohio respectively. Additionally there are 6 more sites running the trial."

Answered by AI

How many people have been admitted for participation in this research?

"This clinical trial necessitates 120 individuals who meet the criteria of inclusion to take part. Patients can join at any one of several sites, including Bay Area Foot Care in San Francisco and Doctor's Research Network in Miami, North carolina."

Answered by AI

Who else is applying?

What site did they apply to?
Martin Foot and Ankle
Barry University Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Barry University Clinical Research: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
2023. "Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06035536.
~47 spots leftby Dec 2024
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