Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.

A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07360418

Acronym

SCANX

Enrollment

Registered

2026-01-22

Start date

2025-10-16

Completion date

2027-10-01

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer, Diabetic Foot Ulcers (DFU), Foot Ulcer Chronic, Ulcer

Keywords

CAMPX, CAMP, Foot Ulcer, diabetic foot ulcer

Brief summary

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

Detailed description

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

OTHERBlue 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of Recurrence	52 weeks	To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone.

Secondary

Measure	Time frame	Description
Virtual Long-Term Follow Up	52 weeks	To evaluate the effectiveness of virtual clinical trial technology in the conduct of a long-term follow up trial.

Countries

United States

Contacts

CONTACTBennett Sarver

info@serenagroups.com1-833-865-6300

CONTACTThomas Serena, MD