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

Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661123
• Other study ID #: Lymphedema,fibrosis
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Eva Nakhla
• Phone: 0201220264801
• Email: dr-evamagdy[@]hotmail.comm
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cellulitis
• Cellulitis of Leg
• Fibrosis
• Lymphedema

Intervention

Other:
• Complete decongestive therapy
Education. Skin care . Pneumatic compression device . Manual lymph draining . Multilayer short stretch compression bandages. Exercises.

Locations

Country	Name	City	State
Egypt	Al Sahel teaching hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess limb volume	using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions	6 weeks
Primary	To assess skin extensibility	using tonometer at the beginning of the study and at last session after 6 weeks	6 weeks
Primary	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	6 weeks
Primary	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	6 weeks