Print

Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

Detroit Foot and Ankle
Clinton Township 4989133, Michigan 5001836 48038
Contact:
Lina Barman

More Details

Status
Recruiting
Sponsor
Applied Biologics, LLC

Study Contact

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

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..

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.