Lower Limb LymphedemaNCT05661123
Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
A study testing Complete decongestive therapy in people with Lower Limb Lymphedema and Fibrosis, run by Cairo University at 1 site in Egypt.
Trial summary
this study will be designed to investigate the therapeutic benefits of kinesio tape in combination to complete decongestive therapy on limb volume , skin fibrosis, functional capacity ,ankle range of motion, lymphedema associated symptoms (pain, tightness, heaviness and hardness) and quality of life in patients with… Read more about this study
- Who is it for?
- Ages 45 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Lymphedema, Fibrosis, Cellulitis of Leg
- What is being tested?
- Complete decongestive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2023to Jun 2024
- 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 45 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient will be according the following criteria:-
- Males and females with Lower limb lymphedema Stage 2.
- Age will range from45 to 55years old.
- BMI <40 (kg/m2).
- All patients will be clinically and medically stable when attending the study.
- Patients free from any acute conditions.
- Post cellulitis for at least 2 weeks.
Who cannot join
- Unstable cardiovascular problems.
- Altered mental status or poor cognition.
- Lower limb ischemia (ABI ≤0.8).
- Lower limb lymphedema stage 3\&4.
- Acute deep venous thrombosis.
- Any acute infection.
- Patients with orthopedic or neurological limitations to exercise.
- Any lower limb acute ulcer or arterial wounds.
Trial locations and contacts
1 site in 1 country.
About this study
this study will be designed to investigate the therapeutic benefits of kinesio tape in combination to complete decongestive therapy on limb volume , skin fibrosis, functional capacity ,ankle range of motion, lymphedema associated symptoms (pain, tightness, heaviness and hardness) and quality of life in patients with lower limbs fibrosis post cellulitis ,as well as finding out a physical therapy approach that has positive effect in treatment and care such cases which would enhance the physical therapy field.
Read the detailed description
Lymphedema patient need a rehabilitative intervention in two phases : decongestion phase to reduce edema volume , improve the skin extensibility and provide him a better quality of life, followed by the maintenance phase to keep the outcomes. When we use the kinesio tape in addition to the complete decongestive therapy, the patient will experience a better improvement in the edema volume and the skin extensibility within a shorter period of time , a lesser number of sessions and a lower cost. So, the patient will have a better quality of life and could be a productive person in the society.
- Conditions
- Lower Limb Lymphedema, Fibrosis, Cellulitis of Leg
- Being tested
- Complete decongestive therapy
- Keywords
- Lymphedema, complete decongestive therapy, kinesio tape
- Medical subject headings
- Fibrosis, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete decongestive therapyOther
- Education.
- Skin care .
- Pneumatic compression device .
- Manual lymph draining .
- Multilayer short stretch compression bandages.
- Exercises.
| Study group | Role | What they receive |
|---|---|---|
| will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks. | Experimental | will receive Complete decongestive therapy in combination with kinesio tape Receives: Other: Complete decongestive therapy |
| will receive complete decongestive therapy for 6 successive weeks. | Other | Complete Decongestive Therapy(traditional physical therapy) that includes:
1. Education.
2. Skin care .
3. Pneumatic compression device .
4. Manual lymph draining .
5. Multilayer short stretch compression bandages.
6. Exercises. Receives: Other: Complete decongestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess limb volume
using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions
Measured: 6 weeks
To assess skin extensibility
using tonometer at the beginning of the study and at last session after 6 weeks
Measured: 6 weeks
To evaluate ankle range of motion
using digital goniometer at the ankle joint to assess the dorsi flexion degree at the beginning of the study and at the last session
Measured: 6 weeks
To evaluate patient quality of life
using Lymphedema life impact scale in form of 18 questions every question' answer from 0 ( no symptoms) to 4 ( sever symptoms) at the beginning of the study and at the end of sessions
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start20 Sep 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb LymphedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Magdy Bottros Nakhla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661123
- Sponsor's protocol ID
- Lymphedema,fibrosis
- Status last verified
- Aug 2023
- First submitted
- 27 Nov 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
- ClinicalTrials.gov ID
- NCT05661123
- Acronym / sponsor ID
- Lymphedema,fibrosis
- Conditions
- Lower Limb Lymphedema, Fibrosis, Cellulitis of Leg
- Keywords
- Lymphedema, complete decongestive therapy, kinesio tape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Dec 2022 (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.
this study will be designed to investigate the therapeutic benefits of kinesio tape in combination to complete decongestive therapy on limb volume , skin fibrosis, functional capacity ,ankle range of motion, lymphedema associated symptoms (pain, tightness, heaviness and hardness) and quality of life in patients with lower limbs fibrosis post cellulitis ,as well as finding out a physical therapy approach that has positive effect in treatment and care such cases which would enhance the physical therapy field.
Detailed description
Lymphedema patient need a rehabilitative intervention in two phases : decongestion phase to reduce edema volume , improve the skin extensibility and provide him a better quality of life, followed by the maintenance phase to keep the outcomes. When we use the kinesio tape in addition to the complete decongestive therapy, the patient will experience a better improvement in the edema volume and the skin extensibility within a shorter period of time , a lesser number of sessions and a lower cost. So, the patient will have a better quality of life and could be a productive person in the society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks. | Experimental | Other: Complete decongestive therapywill receive Complete decongestive therapy in combination with kinesio tape |
| will receive complete decongestive therapy for 6 successive weeks. | Other | Other: Complete decongestive therapyComplete Decongestive Therapy(traditional physical therapy) that includes: 1. Education. 2. Skin care . 3. Pneumatic compression device . 4. Manual lymph draining . 5. Multilayer short stretch compression bandages. 6. Exercises. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patient will be according the following criteria:-
- Males and females with Lower limb lymphedema Stage 2.
- Age will range from45 to 55years old.
- BMI <40 (kg/m2).
- All patients will be clinically and medically stable when attending the study.
Key exclusion criteria (8 listed)
- Unstable cardiovascular problems.
- Altered mental status or poor cognition.
- Lower limb ischemia (ABI ≤0.8).
- Lower limb lymphedema stage 3\&4.
- Acute deep venous thrombosis.
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 |
|---|---|---|
| Complete decongestive therapy1. Education. 2. Skin care . 3. Pneumatic compression device . 4. Manual lymph draining . 5. Multilayer short stretch compression bandages. 6. Exercises. | Other | will receive complete decongestive therapy for 6 successive weeks., will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks. |
Primary outcome
To assess limb volume
Time frame: 6 weeks
using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions
To assess skin extensibility
Time frame: 6 weeks
using tonometer at the beginning of the study and at last session after 6 weeks
To evaluate ankle range of motion
Time frame: 6 weeks
using digital goniometer at the ankle joint to assess the dorsi flexion degree at the beginning of the study and at the last session
To evaluate patient quality of life
Time frame: 6 weeks
using Lymphedema life impact scale in form of 18 questions every question' answer from 0 ( no symptoms) to 4 ( sever symptoms) at the beginning of the study and at the end of sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete decongestive therapy in people with Lower Limb Lymphedema and Fibrosis, run by Cairo University 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Nakhla (0201220264801, dr-evamagdy@hotmail.comm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess limb volume (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 30 Aug 2023.