The Effect of Manual Lymphatic Drainage

Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate

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.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency; Venous Leg Ulcer; Lymphatic Disease
• Intervention / Treatment: Other: Manual Lymphatic drainage (MLD); Other: Skin Care; Other: Exercise; Other: Shame Manual Lymphatic drainage

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Sağlık Bilimleri University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Manual Lymphatic Drainage Group; All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included manual lymphatic drainage on the leg, skin care, bandaging and exercise.	Other: Manual Lymphatic drainage (MLD); MLD vith vodder technique was applied to leg; Other: Skin Care; Wound was cleaned with salin and covered by dressing without including active products; Other: Exercise; breathing and foot pump exercise was prescribed
SHAM_COMPARATOR: Shame Manual Lymphatic Drainage Group; All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included shame manual lymphatic drainage on the leg, skin care, bandaging and exercise. Shame manual lymphatic drainage include light touches instead of real manual lymphatic drainage techniques	Other: Skin Care; Wound was cleaned with salin and covered by dressing without including active products; Other: Exercise; breathing and foot pump exercise was prescribed; Other: Shame Manual Lymphatic drainage; manual lymphatic drainage was applied with light touch instead of real mld techniques

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Collaborators: Istanbul Health Sciences University
• Investigators: Study Director: Nilüfer Kablan, PhD, University of Health Science

Publications and helpful links

General Publications

• Azoubel R, Torres Gde V, da Silva LW, Gomes FV, dos Reis LA. [Effects of the decongestive physiotherapy in the healing of venous ulcers]. Rev Esc Enferm USP. 2010 Dec;44(4):1085-92. doi: 10.1590/s0080-62342010000400033. Portuguese.
• Crawford JM, Lal BK, Duran WN, Pappas PJ. Pathophysiology of venous ulceration. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):596-605. doi: 10.1016/j.jvsv.2017.03.015.
• de Roos KP, Wittens CH, Maessen-Visch MB, van der Wegen-Franken CP. [Universal Dutch guideline on 'Venous disease']. Ned Tijdschr Geneeskd. 2014;158(0):A8076. Dutch.
• Williams A. Manual lymphatic drainage: exploring the history and evidence base. Br J Community Nurs. 2010 Apr;15(4):S18-24. doi: 10.12968/bjcn.2010.15.Sup3.47365.
• Kelechi TJ, Johnson JJ, Yates S. Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003.
• Hampton S. An introduction to various types of leg ulcers and their management. Br J Nurs. 2006 Jun 8-21;15(11):S9-13. doi: 10.12968/bjon.2006.15.Sup2.21235.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2018
• Primary Completion (ACTUAL): July 3, 2019
• Study Completion (ACTUAL): May 29, 2020

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer; Venous Insufficiency; Lymphatic Diseases
• Other Study ID Numbers: 09.2017.209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No