Debritom - Micro Water Jet Technology and Wound Healing

Not Applicable

Terminated

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Micro Water Jet Technology (Debritom)	Debritom	Debritom is a 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. All subject will get the Debritom.

Primary Outcome Measures

Name	Time	Method
Size of Ulcers	Up to 20 weeks or when the ulcer is healed, whichever is sooner.	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.
Leg Rest Pain Score	up to 20 weeks, or when the ulcer is healed, whichever is sooner	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.
Subjects Feedback	At end of their study participation	Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.
Pain During Debridement Score	up to 20 weeks, sooner pending wound healing.	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.