Debritom - Micro Water Jet Technology and Wound Healing

Stephanie Wu2 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer Non-healing Wound Non-Healing Ulcer of Skin Venous Leg Ulcer Venous Ulcer

Interventions

DebritomDEVICE

hydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rosalind Franklin University Health Clinics

North Chicago, Illinois, United States

Outcomes

Primary Outcomes

Size of Ulcers

The extent and size of ulcers (summation of the products of the long x short axis for all ulcers measured in centimeters squared, plus ulcer depth) will be evaluated and photographs of ulcers taken during screening and on all clinic visits up to 20 weeks or when the ulcer is healed, whichever is sooner.

Time frame: Up to 20 weeks or when the ulcer is healed, whichever is sooner.

Leg Rest Pain Score

Leg rest pain score - visual analogue scale (VAS) graded from 0 (pain free) to Grade 10 (maximum pain) during screening and on all clinic visits up to 20 weeks, or when the ulcer is healed, whichever is sooner.

Time frame: up to 20 weeks, or when the ulcer is healed, whichever is sooner

Pain During Debridement Score

Pain during Debridement score - VAS graded from 0 (pain free) to Grade 10 (maximum pain) during on all clinical visits when debridement is performed for up to 20 weeks, sooner pending wound healing.

Time frame: up to 20 weeks, sooner pending wound healing.

Subjects Feedback

Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.

Time frame: At end of their study participation

Data from ClinicalTrials.gov

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