Debritom - Micro Water Jet Technology and Wound Healing

Stephanie Wu

Status: Terminated

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

Treatments: Device: Debritom

Study type: Interventional

Funder types: Other

Identifiers

NCT04240574

MDX-DEB-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Micro Water Jet Technology (Debritom)

Other group

Description:

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.

Treatment:

Device: Debritom