Diabetes Complications, Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Heal, Wound Leg
Conditions
Brief summary
The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system. The investigators will enroll 25 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. The RCT 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.
Detailed description
The purpose of this research is to determine if a smartphone mobile application, also referred to as a mobile app or simply an app, designed to capture wound measurements and analyze wound tissue distribution in real-time, can be a practical patient-centered solution for regular wound management and assessment. The app will be compared to traditional in-person wound monitoring. One of the major limitations of most literature describing remote monitoring technologies is the lack of a control group. By randomizing half of the enrolled patients in the RCT to remote monitoring via standard of care, the investigators will be able to compare patient and provider satisfaction with remote vs. in-person monitoring, as well as the wound healing outcomes.
Interventions
OTHERRemote 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.
Sponsors
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Feasibility Phase: Patients 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. RCT: Patients will be computer randomized 1:1 to receive wound care monitoring using remote diabetic foot ulcer (DFU) monitoring technology or standard in-person monitoring for 12 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A Feasibility - Number of Participants With Wound Scan Completion | 8 weeks | Participants 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 Who Successfully Complete Weekly Wound Scan | 12 weeks | Successful weekly scan rate out of 12 weeks defined as total number of participants who successfully complete a weekly wound scan |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCaitlin Hicks, MD
Johns Hopkins School of Medicine
Participant flow
Recruitment details
Patients with an active diabetic foot ulcer (DFU) were recruited at the Johns Hopkins Hospital multidisciplinary diabetic limb preservation clinic.
Pre-assignment details
Caregivers were not enrolled in the study, however were trained alongside the enrolled participants on how to use the app for scanning.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 55 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 1 / 62 | 1 / 61 |
| other Total, other adverse events | 0 / 25 | 32 / 62 | 22 / 61 |
| serious Total, serious adverse events | 0 / 25 | 20 / 62 | 15 / 61 |
Outcome results
None listed