Trial Outcomes & Findings for A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers (NCT NCT00761176)

Last Updated: 2016-01-05

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

approximate one year

Results posted on

2016-01-05

Participant milestones
Measure	Standard of Care standardized care will be used for wound care on patients randomized to this arm.	Active Provant Therapy Device
Overall Study STARTED	4	4
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal
Measure	Standard of Care standardized care will be used for wound care on patients randomized to this arm.	Active Provant Therapy Device
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	1

A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers

Baseline characteristics by cohort
Measure	Active n=4 Participants The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.	Standard of Care n=4 Participants Standardized wound care is used	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

Timeframe: approximate one year

Population: Analysis was not done as this study was early terminated due to all subjects not meeting inclusion/exclusion criteria.

Outcome data not reported

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Standard of Care n=4 participants at risk standardized care will be used for wound care on patients randomized to this arm.	Active n=4 participants at risk Provant Therapy Device
Skin and subcutaneous tissue disorders Death	25.0% 1/4 • Number of events 1	0.00% 0/4

Adverse event data not reported

Regenesis Biomedical, Inc.

Phone: 602-309-2118