Back to resultsDebritom - Micro Water Jet Technology and Wound Healing
Primary Purpose
Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Debritom
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
Eligibility Criteria
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
Sites / Locations
- Rosalind Franklin University Health Clinics
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Micro Water Jet Technology (Debritom)
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Subjects Feedback
Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04240574
Brief Title
Debritom - Micro Water Jet Technology and Wound Healing
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to pandemic we were not able to recruit patients for this study
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
August 6, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephanie Wu
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin, Venous Leg Ulcer, Venous Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micro Water Jet Technology (Debritom)
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Debritom
Intervention Description
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.
Primary Outcome Measure Information:
Title
Size of Ulcers
Description
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.
Time Frame
Up to 20 weeks or when the ulcer is healed, whichever is sooner.
Title
Leg Rest Pain Score
Description
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.
Time Frame
up to 20 weeks, or when the ulcer is healed, whichever is sooner
Title
Pain During Debridement Score
Description
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.
Time Frame
up to 20 weeks, sooner pending wound healing.
Title
Subjects Feedback
Description
Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.
Time Frame
At end of their study participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rosalind Franklin University Health Clinics
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Will not share
Learn more about this trial
Debritom - Micro Water Jet Technology and Wound Healing
We'll reach out to this number within 24 hrs