Recruiting

Observational Study

Sponsor:

Applied Biologics, LLC

Code:

NCT07360418

Conditions

Diabetic Foot Ulcers (DFU)

Foot Ulcer Chronic

Ulcer

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blue Drop Foot Scanner

Study Details

Brief summary:

Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.

Conditions

Diabetic Foot Ulcers (DFU)

Foot Ulcer Chronic

Ulcer

Diabetic Foot Ulcer

Study ID

NCT07360418

Start date

Oct 16, 2025

Status verified date

Feb, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

OneStep Foot Scanner

This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form.

Interventions

Blue Drop Foot Scanner

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.

Primary outcome measure

  • Rate of Recurrence [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Bennett Sarver

1-833-865-6300info@serenagroups.com

Thomas Serena, MD

1-833-865-6300info@serenagroups.com

Locations

Detroit Foot and Ankle

Recruiting

Clinton Township, Michigan, United States, 48038

More Information

Sponsor

Applied Biologics, LLC

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • CAMPX
  • CAMP
  • Foot Ulcer
  • diabetic foot ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Applied Biologics, LLC on 2026-02-10.