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The Effect of Manual Lymphatic Drainage

Primary Purpose

Venous Leg Ulcer, Venous Insufficiency, Lymphatic Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Lymphatic drainage (MLD)
Skin Care
Exercise
Shame Manual Lymphatic drainage
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Saglık Bilimleri University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Manual Lymphatic Drainage Group

Shame Manual Lymphatic Drainage Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Evaluation of wound healing
Wound was assesed by analyzing photographes of wound with Tracker software.
Evaluation of range of motion of ankle
range of motion of ankle was measured with goniometer
Evaluation of pain
Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.
evaluation of edema
edema was measured by 3D scanner
evaluation of quality of life
quality of life was evaluated by SF- 12

Secondary Outcome Measures

Full Information

First Posted
July 2, 2020
Last Updated
July 2, 2020
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Collaborators
Istanbul Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04461132
Brief Title
The Effect of Manual Lymphatic Drainage
Official Title
Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
May 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Collaborators
Istanbul Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Venous Insufficiency, Lymphatic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Lymphatic Drainage Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Shame Manual Lymphatic Drainage Group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic drainage (MLD)
Intervention Description
MLD vith vodder technique was applied to leg
Intervention Type
Other
Intervention Name(s)
Skin Care
Intervention Description
Wound was cleaned with salin and covered by dressing without including active products
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
breathing and foot pump exercise was prescribed
Intervention Type
Other
Intervention Name(s)
Shame Manual Lymphatic drainage
Intervention Description
manual lymphatic drainage was applied with light touch instead of real mld techniques
Primary Outcome Measure Information:
Title
Evaluation of wound healing
Description
Wound was assesed by analyzing photographes of wound with Tracker software.
Time Frame
Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.
Title
Evaluation of range of motion of ankle
Description
range of motion of ankle was measured with goniometer
Time Frame
Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.
Title
Evaluation of pain
Description
Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.
Time Frame
Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.
Title
evaluation of edema
Description
edema was measured by 3D scanner
Time Frame
Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.
Title
evaluation of quality of life
Description
quality of life was evaluated by SF- 12
Time Frame
Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilüfer Kablan, PhD
Organizational Affiliation
University of Health science
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Saglık Bilimleri University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21337794
Citation
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.
Results Reference
result
PubMed Identifier
28624002
Citation
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.
Results Reference
result
PubMed Identifier
27707417
Citation
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.
Results Reference
result
PubMed Identifier
20559172
Citation
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.
Results Reference
result
PubMed Identifier
26025146
Citation
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.
Results Reference
result
PubMed Identifier
16835515
Citation
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.
Results Reference
result

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The Effect of Manual Lymphatic Drainage

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