Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema

NCT04749342 | Completed DMC

• 1 other identifier: P.T.REC/012/002271
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to: Find out the efficacy of using complete decongestive physiotherapy on limb volume in advanced secondary upper and lower extremity lymphedema patients. Find out the efficacy of compression bandaging on limb volume in advanced lymphedema patients. This study was conducted to compare between the efficacy of complete decongestive therapy (CDT) and compression bandaging in advanced secondary lower extremity lymphedema.

Conditions

Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes

Outcome Measures

Primary Outcomes (1)

• Limb Volume

  girth Limb Measurement

  1 Month

Study Arms (2)

Complete Decongestive Therapy

EXPERIMENTAL

Complete decongestive therapy (CDT) is also known as complex decongestive therapy. It involves a two-stage treatment protocol. The first stage consists of skin care, manual lymph drainage, exercises and compression with multi-layered bandages. The second stage aims to optimize and conserve the volume reduction obtained in stage one. This is achieved by using a low-stretch elastic garment in combination with skin care and exercises

Other: Physiotherapy Treatment

Compression Bandaging

EXPERIMENTAL

External compression is the mainstay of management for all stages of lymphedema. The efficacy of compression therapy alone, or combined with MLD, has been supported by randomized clinical trials

Other: Physiotherapy Treatment

Interventions

Physiotherapy Treatment OTHER

Physical Therapy sessions for treatment of advanced Lymphedema Cases

Complete Decongestive Therapy; Compression Bandaging

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with lower limb lymphedema (stage II and III) secondary lymphedema aged from 40 to 55 years old, with BMI less than 35 and duration of illness ranged from 3-9 years were included in the study

You may not qualify if:

• the patients were excluded if they have acute erysipelas, acute thrombophlebitis phlebothrombosis and decompensated heart failure.

Sponsors & Collaborators

• Ahmed Mohamed Abdelrauf: lead

Study Sites (1)

cairo University

Cairo, Dokky, Giza, Egypt

Location

Study Officials

• Ahmed Mohamed Abdelrauf, Assistant Lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema

Model Details: The purpose of this report is to compare short-term outcomes of complete decongestive therapy and compression bandaging on patients with advanced secondary upper and lower extremity lymphedema.

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 11, 2021
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting in December 2020 - March 2021

Locations

EG (1)