Debritom - Micro Water Jet Technology and Wound Healing

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

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Debritom


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Micro Water Jet Technology (Debritom)<br>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. | Device: Debritom<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | At end of their study participation |