Clinical trial NCT04240574: Debritom - Micro Water Jet Technology and Wound Healing
Official title: Evaluation of Micro Water Jet Technology and the Progression of Wound Healing: A Prospective Cohort Evaluating the Efficacy of Micro Water Jet Technology in the Debridement and Healing of Chronic Lower Extremity Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcer
Non-healing Wound
Non-Healing Ulcer of Skin
Venous Leg Ulcer
Venous Ulcer
Lead sponsor: Rosalind Franklin University of Medicine and Science
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.

Detailed description: This is a prospective cohort, single-center, open-label study in subjects with chronic lower extremity wounds. The study will enroll up to 20 subjects. Subjects will undergo screening evaluations to determine eligibility to enroll in the study. All study subjects will receive micro water jet technology debridement as opposed to other debridement methods as part of their wound care treatment. The other aspects of subjects wound care protocol will remain unchanged. In the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive micro water jet debridement on one or all of the ulcers.

Eligibility criteria: Inclusion Criteria:

* Male or female age 18 or older
* The ability and willingness to provide Informed consent
* Presence of a chronic lower extremity ulcer
* Chronic ulcer is defined as that greater than 4 weeks in duration.
* Subject's informed consent for participation prior to proceeding with micro water jet technology debridement
* Patient's ulcer cannot exhibit any gross clinical signs of infection.
* Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study.
* Patient willing and able to comply with having micro water jet technology debridement potentially weekly or biweekly as part of their wound care treatment plan for up to 20 weeks.

Exclusion Criteria:

* Patients with active wound infection, or untreated osteomyelitis
* Patients with dementia, or impaired cognitive function
* Patients who are unable or unwilling to participate in all procedures and follow up evaluations
* Patient has Active Charcot foot
* Patient with malignant wounds

Primary outcomes:
measure: Size of Ulcers
timeFrame: Up to 20 weeks or when the ulcer is healed, whichever is sooner.
measure: Leg Rest Pain Score
timeFrame: up to 20 weeks, or when the ulcer is healed, whichever is sooner
measure: Pain During Debridement Score
timeFrame: up to 20 weeks, sooner pending wound healing.
measure: Subjects Feedback
timeFrame: At end of their study participation
Secondary outcomes:
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Rosalind Franklin University Health Clinics
state: Illinois
Study officials:
References: