An interventional study of Flexitouch for 1 month in addition to routine wound care and Routine wound care for venous ulcers and lymphedema in Lymphedema, sponsored by NYU Langone Health. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
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.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 39 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
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
Other: Flexitouch for 1 month in addition to routine wound care
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.
Other: Routine wound care for venous ulcers and lymphedema
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.
Device: Flexitouch pneumonic compression
simultaneous wound care and pneumonic compression
wound care /dressings
pneumonic compression only
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
| Milestone | Randomization Arm 1: | Randomization Arm 2: | Observational Arm 3 |
|---|---|---|---|
| Started | 5 | 5 | 29 |
| Completed | 5 | 2 | 29 |
| Not completed | 0 | 3 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Other | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.
No measurements were reported for this outcome.
Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomization Arm 1: | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Randomization Arm 2: | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Observational Arm 3 | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Categorical(Participants) | Randomization Arm 1: | Randomization Arm 2: | Observational Arm 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 12 | 14 |
| >=65 years | 4 | 1 | 17 | 22 |
| Sex: Female, Male(Participants) | Randomization Arm 1: | Randomization Arm 2: | Observational Arm 3 | Total |
|---|---|---|---|---|
| Female | 3 | 1 | 14 | 18 |
| Male | 2 | 1 | 15 | 18 |
| Region of Enrollment(participants) | Randomization Arm 1: | Randomization Arm 2: | Observational Arm 3 | Total |
|---|---|---|---|---|
| United States | 5 | 2 | 29 | 36 |
No study locations are listed for this record.
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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