--- title: Effectiveness of Two Compression Methods in the Treatment of Upper Limb Lymphedema nct_id: NCT02369679 overall_status: COMPLETED phase: NA sponsor: Parc de Salut Mar study_type: INTERVENTIONAL primary_condition: Lymphedema countries: Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02369679.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02369679" ct_last_update_post_date: 2017-04-07 last_seen_at: "2026-05-12T06:58:58.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Effectiveness of Two Compression Methods in the Treatment of Upper Limb Lymphedema **Official Title:** Comparison of the Effectiveness of a Precast Adjustable Compression Wrap With the Multilayer Compression Bandage in Upper Limb Lymphedema **NCT ID:** [NCT02369679](https://clinicaltrials.gov/study/NCT02369679) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 47 - **Lead Sponsor:** Parc de Salut Mar - **Collaborators:** Hospital Universitari de Bellvitge, Germans Trias i Pujol Hospital, Hospital Vall d'Hebron - **Conditions:** Lymphedema - **Start Date:** 2014-10-13 - **Completion Date:** 2017-04-05 - **CT.gov Last Update:** 2017-04-07 ## Brief Summary Treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately.The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system. The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema. ## Detailed Description The gold standard of the treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately. With the multilayer compression bandage the upper limb lymphedema volume decreased a 37.2%. The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system. Decreasing compression is achieved by controlling the tension applied to each Velcro through a visual color guide. The Precast Adjustable Compression Wrap has proved to be safe and effective to treat lower limb lymphedema, but there is little information about its effectiveness in the treatment of the upper limb lymphedema. The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema. ## Eligibility - **Minimum age:** 18 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` Inclusion Criteria: * Upper limb lymphedema after axillary lymph node dissection for breast cancer. * Lymphedema must affect at least the arm or the forearm. * The lymphedema volume excess must be at least 10% * The lymphedema must have not been previously treated or have been at least 1 year without treatment. Exclusion Criteria: * Bilateral upper limb lymphedema * Cognitive or sensorial impairments which could interfere collaboration * Plexopathy post radiotherapy * Breast cancer in progression Pregnancy or Lactation ``` ## Arms - **Precast Adjustable Compression Wrap** (EXPERIMENTAL) — Precast Adjustable Compression Wrap will be adjusted by the physiotherapist each visit - **Multilayer Compression Bandages** (ACTIVE_COMPARATOR) — Multilayer Compression Bandages will be adjusted by the physiotherapist each visit ## Interventions - **Precast Adjustable Compression Wrap (Circaid)** (DEVICE) — A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the precast adjustable compression wrap to the patient. The patient would maintain the precast adjustable compression wrap until the next session of treatment. The first 10 sessions will be daily from Monday to Friday. After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days). - **Multilayer Compression Bandages** (DEVICE) — A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the multilayer bandage to the patient. The patient would maintain the multilayer compression bandage until the next session of treatment. The first 10 sessions will be daily from Monday to Friday. After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days). ## Primary Outcomes - **Change in the excess of volume of upper limb** _(time frame: Baseline to 3 months (10 sessions of treatment))_ — Change in the excess of volume of the affected upper limb. The excess of volume is the difference in volume between the affected and the unaffected upper limb. The upper limb volumes will be obtained from the perimeters of the upper limbs and applying the truncate cone formula. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months ## Secondary Outcomes - **Changes in pain, heaviness, tightness and hardness** _(time frame: Baseline to 3 months (10 sessions of treatment))_ - **Changes in skin and lymphedema condition** _(time frame: Baseline to 3 months (10 sessions of treatment))_ - **Number of Participants with Serious and Non-Serious Adverse Events** _(time frame: Baseline to 3 months (10 sessions of treatment))_ ## Locations (3) - Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain - Hospital Vall Hebron, Barcelona, Barcelona, Spain - Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.germans trias i pujol hospital|badalona|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital vall hebron|barcelona|barcelona|spain` — added _(2026-05-12)_ - `locations.hospital universitari de bellvitge|l'hospitalet de llobregat|barcelona|spain` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02369679.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02369679* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*