Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07360418

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetic Foot Ulcers (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Diseases Foot Ulcer Foot Ulcer Chronic Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Detroit Foot and Ankle

Clinton Township, Michigan, 48038, United States

Location status: Recruiting

Location contact

Lina Barman

CONTACT

About this study

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..

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blue Drop Foot Scanner

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.

Primary outcomes

  1. Rate of Recurrence

    Time frame: 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 outcomes

  1. Virtual Long-Term Follow Up

    Time frame: 52 weeks

    To evaluate the effectiveness of virtual clinical trial technology in the conduct of a long-term follow up trial.

Study contacts

Contact information is provided by the study sponsor or research team.

Bennett Sarver

CONTACT

[email protected]

1-833-865-6300

Thomas Serena, MD

CONTACT

[email protected]

1-833-865-6300

Sponsors and collaborators

Lead sponsor

Applied Biologics, LLC

Industry

Collaborators

  • Serena Group

Registry information

Official study title

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

Acronym: SCANX

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.