Trial Outcomes & Findings for Flexitouch Treatment for Venous Ulcers (NCT NCT00847002)

NCT ID: NCT00847002

Last Updated: 2020-02-12

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-02-12

Participant Flow

Study was stopped early due to slow accrual.

Participant milestones

Measure	Standard of Care Standard Wound Care using compression	Flexitouch System Flexitouch system with Standard Wound Care using compression
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flexitouch Treatment for Venous Ulcers

Baseline characteristics by cohort

Measure	Standard of Care Wound Treatment n=4 Participants Standard Wound Care using compression	Flexitouch System With Standard of Care n=4 Participants Flexitouch system with Standard Wound Care using compression	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
Age, Continuous	59 years STANDARD_DEVIATION 9.8 • n=5 Participants	54 years STANDARD_DEVIATION 18.9 • n=7 Participants	56.5 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The study was stopped early due to lack of enrollment statistical analysis was not completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: The study was stopped early due to lack of enrollment statistical analysis was not completed.

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care Wound Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Flexitouch System With Standard of Care

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard of Care Wound Treatment n=4 participants at risk Standard Wound Care using compression	Flexitouch System With Standard of Care n=4 participants at risk Flexitouch system with Standard Wound Care using compression
Immune system disorders Mild urticaria - Allergic reaction to new food	0.00% 0/4	25.0% 1/4 • Number of events 1
Skin and subcutaneous tissue disorders Bruise - red mark on foot from brace	0.00% 0/4	25.0% 1/4 • Number of events 1

Additional Information

Sunday Hoy, Director of Clinical Research

Tactile Systems Technology, Inc

Phone: 612.355.5100

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60