CompletedNCT04461132Updated Jul 8, 2020

The Effect of Manual Lymphatic Drainage

An interventional study of Manual Lymphatic drainage (MLD) and Skin Care in Venous Leg Ulcer, Venous Insufficiency and Lymphatic Disease, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 9 months after the study started (first participant enrolled Sep 2018, registered Jul 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Venous Leg Ulcer
Venous Insufficiency
Lymphatic Disease

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In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's enrollment of 10 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

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) · Other: Skin Care · Other: Exercise
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 · Other: Exercise · Other: Shame Manual Lymphatic drainage

Interventions

OtherManual Lymphatic drainage (MLD)
MLD vith vodder technique was applied to leg
OtherSkin Care
Wound was cleaned with salin and covered by dressing without including active products
OtherExercise
breathing and foot pump exercise was prescribed
OtherShame Manual Lymphatic drainage
manual lymphatic drainage was applied with light touch instead of real mld techniques

What researchers measure

Primary outcomes

Evaluation of wound healing
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.
Evaluation of range of motion of ankle
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.
Evaluation of pain
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.
evaluation of edema
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.
evaluation of quality of life
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.

Study locations

1 site

Istanbul Saglık Bilimleri University
Istanbul, Turkey

References and documents

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. PubMed 21337794 ↗
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. PubMed 28624002 ↗
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. PubMed 27707417 ↗
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. PubMed 20559172 ↗
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. PubMed 26025146 ↗
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. PubMed 16835515 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04461132
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Collaborators: Istanbul Health Sciences University
Responsible party: Sponsor
First posted: Jul 8, 2020
Start date: Sep 11, 2018
Primary completion: Jul 3, 2019
Completion: May 29, 2020
Last update: Jul 8, 2020

Study contacts

Nilüfer Kablan, PhD

study director · University of Health science

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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