The Effect of Manual Lymphatic Drainage

NCT04461132 | Completed

• 1 other identifier: 09.2017.209
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Venous Leg Ulcer; Venous Insufficiency; Lymphatic Disease

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Manual Lymphatic Drainage Group

ACTIVE COMPARATOR

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

Shame Manual Lymphatic Drainage Group

SHAM COMPARATOR

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

Manual Lymphatic drainage (MLD) OTHER

MLD vith vodder technique was applied to leg

Manual Lymphatic Drainage Group

Skin Care OTHER

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

Manual Lymphatic Drainage Group; Shame Manual Lymphatic Drainage Group

Exercise OTHER

breathing and foot pump exercise was prescribed

Manual Lymphatic Drainage Group; Shame Manual Lymphatic Drainage Group

Shame Manual Lymphatic drainage OTHER

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

Shame Manual Lymphatic Drainage Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• with diabetic mellutus
• with enfection
• with ABI\<0,7
• Patients who have undergone venous vascular surgery
• Patients undergoing active wound closure treatment

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead
• Istanbul Health Sciences University: collaborator

Study Sites (1)

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related 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. doi: 10.1590/s0080-62342010000400033. Portuguese.

  PMID: 21337794 RESULT

• 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.

  PMID: 28624002 RESULT

• 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.

  PMID: 27707417 RESULT

• 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.

  PMID: 20559172 RESULT

• 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.

  PMID: 26025146 RESULT

• 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.

  PMID: 16835515 RESULT

MeSH Terms

Conditions

Varicose Ulcer; Venous Insufficiency; Lymphatic Diseases

Interventions

Manual Lymphatic Drainage; Skin Care; Exercise

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Hygiene; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nilüfer Kablan, PhD

  University of Health science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: September 11, 2018
• Primary Completion: July 3, 2019
• Study Completion: May 29, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

TU (1)