The Effect of Manual Lymphatic Drainage

Not Applicable

Completed

• Conditions: Venous Insufficiency; Lymphatic Disease; Venous Leg Ulcer

• Registration Number: NCT04461132
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Brief Summary

In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation, enabling nutrients and oxygen to reach tissues and at the same time removing residual substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD, we could stimulate healing of ulcer. The aim of this study to investigate the effect of manual lymphatic drainage on venous ulcer healing.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-11
• Primary Completion: 2019-07-03
• Study Completion: 2020-05-29
• Status Verified: 2020-07
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• with venous ulcer unhealing for at least 6 weeks
• Without enfection
• vascular surgery is not indicated
• There is no obstruction to apply MLD and compression to lower extremty

Exclusion Criteria

• with diabetic mellutus
• with enfection
• with ABI<0,7
• Patients who have undergone venous vascular surgery
• Patients undergoing active wound closure treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of pain	Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.	Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.
Evaluation of wound healing	Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.	Wound was assesed by analyzing photographes of wound with Tracker software.
Evaluation of range of motion of ankle	Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.	range of motion of ankle was measured with goniometer
evaluation of edema	Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.	edema was measured by 3D scanner
evaluation of quality of life	Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.	quality of life was evaluated by SF- 12

Trial Locations

Locations (1)

Istanbul Saglık Bilimleri University; 🇹🇷 Istanbul, Turkey