The Effect of Manual Lymphatic Drainage

NCT ID: NCT04461132

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2020-05-29

Brief Summary

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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

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Conditions

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Venous Leg Ulcer Venous Insufficiency Lymphatic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Manual Lymphatic drainage (MLD)

Intervention Type OTHER

MLD vith vodder technique was applied to leg

Skin Care

Intervention Type OTHER

Wound was cleaned with salin and covered by dressing without including active products

Exercise

Intervention Type OTHER

breathing and foot pump exercise was prescribed

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

Group Type SHAM_COMPARATOR

Skin Care

Intervention Type OTHER

Wound was cleaned with salin and covered by dressing without including active products

Exercise

Intervention Type OTHER

breathing and foot pump exercise was prescribed

Shame Manual Lymphatic drainage

Intervention Type OTHER

manual lymphatic drainage was applied with light touch instead of real mld techniques

Interventions

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Manual Lymphatic drainage (MLD)

MLD vith vodder technique was applied to leg

Intervention Type OTHER

Skin Care

Wound was cleaned with salin and covered by dressing without including active products

Intervention Type OTHER

Exercise

breathing and foot pump exercise was prescribed

Intervention Type OTHER

Shame Manual Lymphatic drainage

manual lymphatic drainage was applied with light touch instead of real mld techniques

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Health Sciences University

UNKNOWN

Sponsor Role collaborator

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nilüfer Kablan, PhD

Role: STUDY_DIRECTOR

University of Health science

Locations

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Istanbul Saglık Bilimleri University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 21337794 (View on PubMed)

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.

Reference Type RESULT
PMID: 28624002 (View on PubMed)

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.

Reference Type RESULT
PMID: 27707417 (View on PubMed)

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.

Reference Type RESULT
PMID: 20559172 (View on PubMed)

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.

Reference Type RESULT
PMID: 26025146 (View on PubMed)

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.

Reference Type RESULT
PMID: 16835515 (View on PubMed)

Other Identifiers

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09.2017.209

Identifier Type: -

Identifier Source: org_study_id

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