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NCT06549738
Effects of Intermittent Pneumatic Compression Therapy on Tissue Volume, Pain, and Quality of Life in Lipedema
NA trial testing Intermittent pneumatic compression therapy in Lipedema in 46 participants. Completed in 16 November 2023.
16 November 2023
Quick facts
| Lead sponsor | Lympha Press |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 21 August 2023 |
| Primary completion | 16 November 2023 |
| Estimated completion | 16 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Intermittent pneumatic compression therapy
Conditions studied
- Lipedema — all drugs for Lipedema →
Sponsor
Lympha Press
Who can join
Adults 18 to 70, female only, with Lipedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lipedema is an inflammatory and painful disease of subcutaneous adipose tissue (SAT) in women that is associated with vein disease and lymphedema. There is controversy on whether there is edema in lipedema. This study seeks to determine: 1. Is there is edema in lipedema? 2. Can edema, lipedema subcutaneous adipose tissue (SAT), symptoms, and quality of life be improved by an advanced intermittent pneumatic compression device (IPCD)? During the course of the study subjects will be seen three times in the clinic for assessment and measurements. All subjects will be provided a compression legging at the first clinic visit. Half of the subjects (the treatment group) will be provided and use an advanced intermittent pneumatic compression device with pants-type appliance that applies dynamic compression therapy to the abdomen, hips, buttocks, legs and feet, starting at the second visit, for 30 days at home, along with daytime use of the compression legging. The other half (the control group) will use the compression leggings only. At the third visit, final measurements will be obtained. The measurements in the study include volume measurements using tape measure and a scanner; body composition measurements (bioimpedance); ultrasound and biopsy of the skin; timed walking and gait measurements; and questionnaires about pain and quality of life. Deidentified (without names) patient medical records will be examined for information on vein disease, body mass index, weight, age, and stage of lipedema (any stage or type). After the third visit, results will be analyzed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06549738
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lipedema
Currently open trials in the same condition.
- NCT07489248 — Multimodal Ultrasound for Differentiating Lymphedema and Lipedema · recruiting
- NCT07468097 — The Impact of Metabolic Status on Pain and Central Sensitization in Women With Lipedema: A Cross-Sectional Observational · recruiting
- NCT07294014 — Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema · recruiting
- NCT07458932 — Evaluation of Physical Activity in Women With Lipedema · recruiting
- NCT06558851 — The Effect of Systematic Endurance Training in Treatment of Women With Lipedema · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06549738 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lympha Press
- Last refreshed: 12 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06549738.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing