The Effect of Manual Lymphatic Drainage

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461132
• Other study ID #: 09.2017.209
• Status: Completed
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: May 29, 2020

Study information

• Verified date: July 2020
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 29, 2020
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Lymphatic Disease
• Lymphatic Diseases
• Varicose Ulcer
• Venous Insufficiency
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Saglik Bilimleri University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey	Istanbul Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. Portuguese. — View Citation

Crawford JM, Lal BK, Durán 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. Review. — View 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. Review. Dutch. — View 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. Review. — View 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. Review. — View Citation

Williams A. Manual lymphatic drainage: exploring the history and evidence base. Br J Community Nurs. 2010 Apr;15(4):S18-24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.