How long healed diabetic foot ulcers stay closed after CAMPX treatment
A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial
This follow-up tests whether diabetic foot ulcers that fully closed by 12 weeks in the CAMPX trial stay closed over a year using home photographic and thermal scans with the BlueDrop OneStep Foot Scanner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Applied Biologics, LLC Industry-sponsored |
| Locations | 1 site (Clinton Township, Michigan) |
| Trial ID | NCT07360418 on ClinicalTrials.gov |
What this trial studies
This is a prospective long-term follow-up of participants from the CAMPX randomized, controlled trial who achieved complete wound closure at the 12-week endpoint. After signing consent, participants will receive instruction and written guidance on using the BlueDrop OneStep Foot Scanner for home photographic and thermal imaging. Data will be collected at roughly 3, 6, 9, and 12 months, with questionnaires used for participants unable to perform scanner measurements. The primary focus is durability of closure as documented by images and thermal scans over the 12-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are former CAMPX participants who achieved complete wound closure by the 12-week endpoint and can consent to home scanning or telephone questionnaire follow-up.
Not a fit: Patients who did not participate in CAMPX or who did not achieve complete closure at 12 weeks are not eligible and are unlikely to benefit from this follow-up.
Why it matters
Potential benefit: If successful, the results could show how long closures last and help clinicians personalize follow-up and wound-care decisions to reduce recurrences.
How similar studies have performed: Photographic and thermal remote monitoring for wound surveillance has shown promise in prior studies, but direct long-term durability data following CAMPX treatment are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint. Exclusion Criteria: * The potential subject did not participate in the CAMPX trial. * The potential subject participated in the CAMPX trial and did not achieve complete closure.
Where this trial is running
Clinton Township, Michigan
- Detroit Foot and Ankle — Clinton Township, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Bennett Sarver
- Email: info@serenagroups.com
- Phone: 1-833-865-6300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.