Edema Due to Obstruction of Lymph Vessels or Excision of Lymph NodesNCT04749342
Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema
A study testing Physiotherapy Treatment in people with Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes, run by Ahmed Mohamed Abdelrauf at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes
- What is being tested?
- Physiotherapy Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- the patients were excluded if they have acute erysipelas, acute thrombophlebitis phlebothrombosis and decompensated heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- Physiotherapy Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy TreatmentOther
Physical Therapy sessions for treatment of advanced Lymphedema Cases
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Physiotherapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Volume
girth Limb Measurement
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2019
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema Due to Obstruction of Lymph Vessels or Excision of Lymph NodesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Abdelrauf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Abdelrauf, Cairo University
- Investigators
- Ahmed Mohamed Abdelrauf, Assistant Lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749342
- Sponsor's protocol ID
- P.T.REC/012/002271
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: (all collected IPD, all IPD that underlie results in a publication)
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema
- ClinicalTrials.gov ID
- NCT04749342
- Acronym / sponsor ID
- P.T.REC/012/002271
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ahmed Mohamed AbdelraufUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Complete Decongestive Therapy | Experimental | Other: Physiotherapy TreatmentComplete 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 |
| Compression Bandaging | Experimental | Other: Physiotherapy TreatmentExternal 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 |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- the patients were excluded if they have acute erysipelas, acute thrombophlebitis phlebothrombosis and decompensated heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy TreatmentPhysical Therapy sessions for treatment of advanced Lymphedema Cases | Other | Complete Decongestive Therapy, Compression Bandaging |
Primary outcome
Limb Volume
Time frame: 1 Month
girth Limb Measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: Yes. (all collected IPD, all IPD that underlie results in a publication)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mohamed Abdelrauf, Assistant Lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Treatment in people with Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes, run by Ahmed Mohamed Abdelrauf at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Volume (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.