Trial Outcomes & Findings for Flexitouch Compression System for Venous Stasis Ulcer (NCT NCT00534937)

NCT ID: NCT00534937

Last Updated: 2013-03-01

Results Overview

Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 89 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2013-03-01

Participant Flow

Recruitment occurred at medical clinics. The first subject was enrolled in November 2007. The subjects were recruited from current patient populations and new patients coming to the clinic. Advertisement materials were used to increase enrollment with little success.

Participant milestones

Measure	Standard Compression Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).	Flexitouch Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Overall Study STARTED	42	47
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	8	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flexitouch Compression System for Venous Stasis Ulcer

Baseline characteristics by cohort

Measure	Standard Compression n=42 Participants Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).	Flexitouch n=47 Participants Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).	Total n=89 Participants Total of all reporting groups
Age Continuous	56.6 years STANDARD_DEVIATION 14.3 • n=5 Participants	57.4 years STANDARD_DEVIATION 16.1 • n=7 Participants	57.0 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex/Gender, Customized Female	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
Sex/Gender, Customized Male	28 participants n=5 Participants	33 participants n=7 Participants	61 participants n=5 Participants
Sex/Gender, Customized Unknown	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.

Outcome measures

Measure	Standard Compression n=42 Participants Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).	Flexitouch n=47 Participants Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Complete Healing Rate of Venous Stasis Ulcers	19 participants	20 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The participants are those that didn't achieve complete wound healing after 12 weeks of treatment. The change from screening to week 12 in wound surface area is reported.

Change in wound surface area in cm2 from the initial screening to week 12 for all subject who did not completely healed before or at the 12 week visit.

Outcome measures

Measure	Standard Compression n=17 Participants Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).	Flexitouch n=15 Participants Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Change in Wound Surface Area for Non Healed Subject at 12 Weeks.	-8.1 cm2 Standard Deviation 9.8	-9.6 cm2 Standard Deviation 11.3

SECONDARY outcome

Timeframe: 12 weeks

Population: Number of participants who completed 12 weeks of treatment without healing. Also limb volume measures must have been present.

Outcome measures

Measure	Standard Compression n=17 Participants Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).	Flexitouch n=16 Participants Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Percentage Change in Volume of the Affected Limb (-Reduction; +Increase)	-2.9 percentage of change Standard Deviation 34.1	-7 percentage of change Standard Deviation 29.1

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Time to healing can only evaluate the patients that showed healing during the 12 week study therefore the number may not be consistent with other numbers.

Only 2 time points so no calculation details are necessary. The change is calculated as the later time point minus the earlier time point (e.g., 12 weeks minus baseline).

Outcome measures

Measure	Standard Compression n=19 Participants Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).	Flexitouch n=20 Participants Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Time to Healing of the Venous Stasis Ulcer	37 days Standard Deviation 24.9	43.9 days Standard Deviation 22.3

Adverse Events

Standard Compression

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Flexitouch

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Compression n=42 participants at risk Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).	Flexitouch n=47 participants at risk Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Infections and infestations Cellulitis / Infection of lower extremity	7.1% 3/42 • Number of events 3 • AEs were collected form 2007 to 2010 at the time of study closure.	0.00% 0/47 • AEs were collected form 2007 to 2010 at the time of study closure.

Other adverse events

Measure	Standard Compression n=42 participants at risk Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).	Flexitouch n=47 participants at risk Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Infections and infestations Cellulitis / Infection of lower extremity	19.0% 8/42 • Number of events 8 • AEs were collected form 2007 to 2010 at the time of study closure.	12.8% 6/47 • Number of events 6 • AEs were collected form 2007 to 2010 at the time of study closure.

Additional Information

Dr. Satish Muluk

Allegheny General Hospital

Phone: (412) 359-3714

Email: muluk@usa.net

Results disclosure agreements

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

Restriction type: LTE60