NCT04240574

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Stephanie Wu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-24
• Primary completion: 2021-08-06
• Completion: 2021-08-06
• First posted: 2020-01-27
• Last updated: 2023-03-27
• Results posted: 2023-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study