The Effect of Manual Lymphatic Drainage

Study Overview
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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.

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

Conditions
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Venous Leg Ulcer, Venous Insufficiency, Lymphatic Disease

Intervention / Treatment
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* Other: Manual Lymphatic drainage (MLD)
* Other: Skin Care
* Other: Exercise
* Other: Shame Manual Lymphatic drainage


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Lymphatic Drainage Group<br>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)<br>* MLD vith vodder technique was applied to leg<br>Other: Skin Care<br>* Wound was cleaned with salin and covered by dressing without including active products<br>Other: Exercise<br>* breathing and foot pump exercise was prescribed<br>|
| Sham Comparator: Shame Manual Lymphatic Drainage Group<br>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<br>* Wound was cleaned with salin and covered by dressing without including active products<br>Other: Exercise<br>* breathing and foot pump exercise was prescribed<br>Other: Shame Manual Lymphatic drainage<br>* manual lymphatic drainage was applied with light touch instead of real mld techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |