Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blue Drop Foot Scanner.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcers (DFU), Foot Ulcer Chronic, Ulcer, Diabetic Foot Ulcer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial
Overview
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
- Other 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 measures
- Rate of Recurrence [Time frame: 52 weeks]
Secondary outcome measures (1)
- Virtual Long-Term Follow Up [Time frame: 52 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Detroit Foot and Ankle — Clinton Township
Identifiers
NCT: NCT07360418 · Pro00084454