Debritom - Micro Water Jet Technology and Wound Healing

NCT04240574 | Terminated Results FDA Device

• 1 other identifier: MDX-DEB-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Micro Water Jet Technology (Debritom)

OTHER

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

Interventions

Debritom DEVICE

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.

Micro Water Jet Technology (Debritom)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie Wu: lead

Study Sites (1)

Rosalind Franklin University Health Clinics

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Limitations and Caveats

Early termination of study due to pandemic. The study was not able to be completed. The early termination lead to only two subjects taking part of the study.

Results Point of Contact

• Title: Jacque Ortiz
• Organization: Rosalind Franklin University

jacquelyn.ortiz@rosalindfranklin.edu

847-578-8423

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 27, 2020
• Study Start: January 24, 2020
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: March 27, 2023
• Results First Posted: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)