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Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Physiotherapy Treatment
Sponsored by
Ahmed Mohamed Abdelrauf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Complete Decongestive Therapy

Compression Bandaging

Arm Description

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

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

Outcomes

Primary Outcome Measures

Limb Volume
girth Limb Measurement

Secondary Outcome Measures

Full Information

First Posted
February 6, 2021
Last Updated
July 14, 2021
Sponsor
Ahmed Mohamed Abdelrauf
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1. Study Identification

Unique Protocol Identification Number
NCT04749342
Brief Title
Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema
Official Title
Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed Abdelrauf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study was conducted at the department of plastic surgery, Kasr Al-Ainy hospital. Sixty patients of both genders aged from 40 to 55 years old were participated in this study, and they were randomly assigned to two study groups. Group I: Thirty patients received CDT (60 min of manual lymph drainage MLD, compression bandaging, exercises, and skin care). Group II: Thirty patients received compression bandaging alone. The same bandaging scheme used for both groups. The therapy included 12 interventions performed 5 days a week, during the first two weeks in addition to another successive two sessions at the third week, i.e., for a total of twelve sessions. Evaluation of limb volume using water volumetry and 4-cm truncated cone circumferential measurements were done before treatment application, after 6 sessions (post 1) and after 12 sessions (post 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete Decongestive Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Compression Bandaging
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Physiotherapy Treatment
Intervention Description
Physical Therapy sessions for treatment of advanced Lymphedema Cases
Primary Outcome Measure Information:
Title
Limb Volume
Description
girth Limb Measurement
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: the patients were excluded if they have acute erysipelas, acute thrombophlebitis phlebothrombosis and decompensated heart failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Abdelrauf, Assistant Lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
cairo University
City
Cairo
State/Province
Dokky, Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
(all collected IPD, all IPD that underlie results in a publication)
IPD Sharing Time Frame
Starting in December 2020 - March 2021

Learn more about this trial

Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema

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