Trial Outcomes & Findings for Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers (NCT NCT05579743)

Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

Participants received standard in-person monitoring and follow-up in clinic on a biweekly basis for a wound check and care plan update as needed (week 2, 4, 6, 8, 10, 12).

Participants received Remote wound monitoring technology and in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments were electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up occurred monthly (at the time of enrollment, week 4, week 8, and week 12).

Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

Participants received standard in-person monitoring and follow-up in clinic on a biweekly basis for a wound check and care plan update as needed (week 2, 4, 6, 8, 10, 12).

Participants received Remote wound monitoring technology and in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments were electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up occurred monthly (at the time of enrollment, week 4, week 8, and week 12).

n=25 Participants

Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

n=59 Participants

Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed.

n=53 Participants

Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12). Remote wound monitoring technology: Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely.

n=137 Participants

Total of all reporting groups

n=25 Participants

Participants and caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

Participants received standard in-person monitoring and follow-up in clinic on a biweekly basis for a wound check and care plan update as needed (week 2, 4, 6, 8, 10, 12).

n=53 Participants

Participants and caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

Participants received standard in-person monitoring and follow-up in clinic on a biweekly basis for a wound check and care plan update as needed (week 2, 4, 6, 8, 10, 12).

n=25 participants at risk

Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

n=62 participants at risk

Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed.

n=61 participants at risk

Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12). Remote wound monitoring technology: Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely.

n=25 participants at risk

Participants and their caregivers were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

n=62 participants at risk

Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed.

n=61 participants at risk

Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12). Remote wound monitoring technology: Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely.