Venous Leg Ulcer Clinical Trial
Official title:
Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate
Verified date | July 2020 |
Source | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Saglik Bilimleri University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey | Istanbul Health Sciences University |
Turkey,
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
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. |
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