Lymphedema
Conditions
Brief summary
The purpose of this study is to evaluate the effect of pneumatic compression in improving symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.
Detailed description
This investigation is a randomized clinical trial of a prospective cohort of an estimated 140 subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms: Randomization Arm 1: 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded. Randomization Arm 2: 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded. Observational Arm 3: 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
Interventions
OTHERFlexitouch for 1 month in addition to routine wound care
simultaneous wound care and pneumonic compression
OTHERRoutine wound care for venous ulcers and lymphedema
wound care /dressings
DEVICEFlexitouch pneumonic compression
pneumonic compression only
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This investigation is a randomized clinical trial of a prospective cohort of subjects with venous ulcers, with an observational cohort of 50 subjects with lymphedema. Venous ulcer subjects will be randomized into two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of a venous ulcer on the lower extremity for at least 12 weeks14 days * Presence of lymphedema in the lower extremity for at least 14 days
Exclusion criteria
* Pregnant women or women of childbearing potential not on contraception * Previous use of the pneumatic compression device * Class IV congestive heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire | 30 days | Study was terminated due to inadequate enrollment. No data was collected for this outcome measure. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomization Arm 1: 70 subjects with venous ulcers will receive pneumatic compression with the Flexitouch® for the duration of one month in addition to routine care of venous ulcers and lymphedema. A pre- and post-PCD treatment CIVIQ-2 quality of life questionnaire will be administered to the subjects. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded
Flexitouch for 1 month in addition to routine wound care: simultaneous wound care and pneumonic compression | 5 |
| Randomization Arm 2: 70 subjects with venous ulcers will receive routine care of venous ulcers and lymphedema. A quality of life questionnaire will be administered at enrollment and again after one month. For subjects with venous ulcers, wound area pre- and post-treatment will be recorded.
Routine wound care for venous ulcers and lymphedema: wound care /dressings | 2 |
| Observational Arm 3 50 subjects with lymphedema will ALL receive PCD treatment. A pre-and post- PCD treatment CIVIQ-2 QOL questionnaire will be administered to all subjects at enrollment and again after one month of treatment.
Flexitouch pneumonic compression: pneumonic compression only | 29 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Randomization Arm 1: | Randomization Arm 2: | Observational Arm 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 17 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 12 Participants | 14 Participants |
| Region of Enrollment United States | 5 participants | 2 participants | 29 participants | 36 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 14 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 15 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 2 | 0 / 29 |
| other Total, other adverse events | 0 / 5 | 0 / 2 | 0 / 29 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 | 0 / 29 |
Outcome results
Primary
To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
Time frame: 30 days
Population: Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.