Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic
This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients wit
| Condition(s) | Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg, Wound Heal, Diabetes Complications |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks. |
| Who can participate | Inclusion Criteria: * Male or female, aged ≥ 18 years old * In treatment for lower extremity wound related to diabetic foot ulcer * Able and willing to use a smartphone to assess the wound for the duration of the study * English language proficiency Exclusion Criteria: * Patients with less than 1 dressing change per week * Patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg) * Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Johns Hopkins University |
| Locations | Baltimore, Maryland, United States |
| Start date | 2023-01-06 |
| NCT ID | NCT05579743 |
| Official listing | https://clinicaltrials.gov/study/NCT05579743 |