What this study is
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
What's being tested
- Blue Drop Foot Scanner
Intervention · OTHER
Subjects with eligible wound will receive a BlueDrop® OneStep Foot Scanner™. They are instructed to step on the scale each morning. The Bluetooth technology transmits a photograph and thermal image to the central monitoring nurse at BlueDrop®. All information transmitted is compliant with HIPPA regulations. Subjects that are unable to use the scale will receive a phone call at months 3,6, 9 and 12 months to determine if the foot has remained closed.
Study details
- Official title
- A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial
- Sponsor
- Applied Biologics, LLC
- Conditions
- Diabetic Foot Ulcers (DFU) · Foot Ulcer Chronic · Ulcer · Diabetic Foot Ulcer
- Enrolling
- 50 people
- Starts
- 2025-10-16
- Est. completion
- 2027-10
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.
You can't join if
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and did not achieve complete closure.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDetroit Foot and Ankle
Clinton Township, Michigan, United States
- Lina Barman · Contact
Recruiting
Study team
Sponsor
Applied Biologics, LLC
Study ID Pro00084454
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.