Volumetric Muscle Loss
Conditions
Brief summary
The purpose of this research is to evaluate the ability of a Nitric Oxide (NO) Sensor to collect NO measurement data from an open wound. Previous research suggests that NO levels may indicate the stage of healing the wound is in. This study is being done to determine if the NO Sensor can measure how much NO is in a participant's wound. The researcher will place the NO Sensor into a participant's wound to collect NO measurements for 30-60 minutes. The participant will then have 2 follow-up appointments to see how the wound heals over time.
Interventions
DEVICENO Sensor
NO sensor measuring wound characteristic data in wound bed
Sponsors
Defense Advanced Research Projects Agency
Stephen Badylak
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
proof of concept
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Extremity injury 2. Wound surface area 2-10 cm in diameter 3. Wound amenable to NO Sensor placement 4. Age at the time of consent ≥ 22 to ≤ 65 years 5. Cognitively able to undergo informed consent discussion and understand the study
Exclusion criteria
1. Chemotherapy 2. Pregnancy 3. Preexisting immunosuppressive conditions or immunosuppression therapy 4. Active hemorrhage in the wound bed 5. Physician discretion for patients with complex medical conditions or high mortality risks 6. Patients with an active implanted device, such as a pacemaker, defibrillator, or hypoglossal or vagal nerve stimulator 7. Patients requiring a legally authorized representative (LAR) for informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01 | up to 8 weeks | — |
| All wound characteristics documented - a minimum of 5 wounds assessed by Bates-Jensen Wound Assessment Tool. And documented in CRF-03 | Day 0 | — |
| NO Sensor application time > 30 minutes and < 60 minutes - a minimum of 5 wounds have NO sensor applied between 30-60 minutes and documented in CRF-04 | 60 minutes | — |
| NO Sensor applied and removed according to study specific SOPs - a minimum of 5 wounds have NO Sensor applied and removed according to study specific SOPs and documented in CRF-04 | Day 0 | — |
| Assessment of wound healing during participant follow-up activities - a minimum of 5 participants have follow up wound assessments according to visit schedule and documented in CRF-05 and CRF-06 | up to 8 weeks | A follow up phone call within 72 hours and an in-person clinic visit within 2-8 weeks of NO Sensor application |
Countries
United States
Outcome results
None listed