Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis

August 28, 2023 updated by: Eva Magdy Bottros Nakhla, Cairo University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Al Sahel teaching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The patient will be according the following criteria:-

  1. Males and females with Lower limb lymphedema Stage 2.
  2. Age will range from45 to 55years old.
  3. BMI <40 (kg/m2).
  4. All patients will be clinically and medically stable when attending the study.
  5. Patients free from any acute conditions.
  6. Post cellulitis for at least 2 weeks.

Exclusion Criteria:

  1. Unstable cardiovascular problems.
  2. Altered mental status or poor cognition.
  3. Lower limb ischemia (ABI ≤0.8).
  4. Lower limb lymphedema stage 3&4.
  5. Acute deep venous thrombosis.
  6. Any acute infection.
  7. Patients with orthopedic or neurological limitations to exercise.
  8. Any lower limb acute ulcer or arterial wounds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks.
will receive Complete decongestive therapy in combination with kinesio tape
Other: Complete decongestive therapy
  1. 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.

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.
Other: Complete decongestive therapy
  1. Education.
  2. Skin care .
  3. Pneumatic compression device .
  4. Manual lymph draining .
  5. Multilayer short stretch compression bandages.
  6. Exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 weeks
To assess skin extensibility
Time Frame: 6 weeks
using tonometer at the beginning of the study and at last session after 6 weeks
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
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Lymphedema,fibrosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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