Debritom - Micro Water Jet Technology and Wound Healing

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

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

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Venous Ulcer; Non-healing Wound; Non-Healing Ulcer of Skin
• Intervention / Treatment: Device: Debritom

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Rosalind Franklin University Health Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Micro Water Jet Technology (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.	Device: Debritom; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stephanie Wu

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: MDX-DEB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will not share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes