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OpenTrials
Completed

NCT Number: NCT04461132

The Effect of Manual Lymphatic Drainage

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.

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Hemic and Lymphatic Diseases Leg Ulcer Lymphatic Disease Lymphatic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Insufficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Lymphatic Drainage (MLD)

Other

MLD vith vodder technique was applied to leg

Skin care

Other

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

Exercise

Other

breathing and foot pump exercise was prescribed

Shame Manual Lymphatic drainage

Other

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

Primary outcomes

  1. Evaluation of wound healing

    Time frame: Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.

    Wound was assesed by analyzing photographes of wound with Tracker software.

  2. Evaluation of range of motion of ankle

    Time frame: Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.

    range of motion of ankle was measured with goniometer

  3. Evaluation of pain

    Time frame: Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.

    Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.

  4. evaluation of edema

    Time frame: Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.

    edema was measured by 3D scanner

  5. evaluation of quality of life

    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.

    quality of life was evaluated by SF- 12

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Collaborators

  • Istanbul Health Sciences University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 8, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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