Trial Outcomes & Findings for Debritom - Micro Water Jet Technology and Wound Healing (NCT NCT04240574)

Last Updated: 2023-03-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

Up to 20 weeks or when the ulcer is healed, whichever is sooner.

Results posted on

2023-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Up to 20 participants may be recruited.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Debritom - Micro Water Jet Technology and Wound Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Treatments n=2 Participants All study subjects will receive micro water jet technology debridement as opposed to traditional debridement using instruments or other means of debridement. Other aspects of subjects wound care protocol will remain unchanged.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 20 weeks or when the ulcer is healed, whichever is sooner.

Population: Data not collected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 20 weeks, or when the ulcer is healed, whichever is sooner

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 20 weeks, sooner pending wound healing.

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At end of their study participation

Population: Data not collected.

Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacque Ortiz

Rosalind Franklin University

Phone: 847-578-8423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place