Debritom - Micro Water Jet Technology and Wound Healing

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04240574
• Other study ID #: MDX-DEB-001
• Status: Terminated
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: August 6, 2021

Study information

• Verified date: March 2023
• Source: Rosalind Franklin University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Non-Healing Ulcer of Skin
• Non-healing Wound
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Venous Ulcer
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Rosalind Franklin University Health Clinics	North Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie Wu

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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.
Primary	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