Venous Leg UlcerNCT04461132
The Effect of Manual Lymphatic Drainage
A study testing Manual Lymphatic drainage (MLD), Skin Care and Exercise in people with Venous Leg Ulcer and Venous Insufficiency, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Leg Ulcer, Venous Insufficiency, Lymphatic Disease
- What is being tested?
- Manual Lymphatic drainage (MLD), Skin Care and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2018to 29 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- with diabetic mellutus
- with enfection
- with ABI<0,7
- Patients who have undergone venous vascular surgery
- Patients undergoing active wound closure treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate
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
- Being tested
- Manual Lymphatic drainage (MLD), Skin Care, Exercise, Shame Manual Lymphatic drainage
- Medical subject headings
- Varicose Ulcer, Venous Insufficiency, Lymphatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic drainage (MLD)Other
MLD vith vodder technique was applied to leg
Skin CareOther
Wound was cleaned with salin and covered by dressing without including active products
ExerciseOther
breathing and foot pump exercise was prescribed
Shame Manual Lymphatic drainageOther
manual lymphatic drainage was applied with light touch instead of real mld techniques
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Skin Care; Other: Exercise; Other: Shame Manual Lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of wound healing
Wound was assesed by analyzing photographes of wound with Tracker software.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start11 Sep 2018
- Primary completion3 Jul 2019
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Health Sciences University
- Responsible party
- Sponsor
- Investigators
- Nilüfer Kablan, PhD, Study director, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461132
- Sponsor's protocol ID
- 09.2017.209
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21337794Crawford 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.
PubMed 28624002de 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.
PubMed 27707417Williams 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.
PubMed 20559172Kelechi 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.
PubMed 26025146Hampton 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.
PubMed 16835515
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate
- ClinicalTrials.gov ID
- NCT04461132
- Acronym / sponsor ID
- 09.2017.209
- Conditions
- Venous Leg Ulcer, Venous Insufficiency, Lymphatic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Collaborators
- Istanbul Health Sciences University
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage Group | Active comparator | Other: Manual Lymphatic drainage (MLD), Other: Skin Care, Other: ExerciseAll 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. |
| Shame Manual Lymphatic Drainage Group | Sham comparator | Other: Skin Care, Other: Exercise, Other: Shame Manual Lymphatic drainageAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- with diabetic mellutus
- with enfection
- with ABI<0,7
- Patients who have undergone venous vascular surgery
- Patients undergoing active wound closure treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymphatic drainage (MLD)MLD vith vodder technique was applied to leg | Other | Manual Lymphatic Drainage Group |
| Skin CareWound was cleaned with salin and covered by dressing without including active products | Other | Manual Lymphatic Drainage Group, Shame Manual Lymphatic Drainage Group |
| Exercisebreathing and foot pump exercise was prescribed | Other | Manual Lymphatic Drainage Group, Shame Manual Lymphatic Drainage Group |
| Shame Manual Lymphatic drainagemanual lymphatic drainage was applied with light touch instead of real mld techniques | Other | Shame Manual Lymphatic Drainage Group |
Primary outcome
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.
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Results publication: PubMed 21337794Azoubel 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.
- Results publication: PubMed 28624002Crawford 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.
- Results publication: PubMed 27707417de 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.
- Results publication: PubMed 20559172Williams 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.
- Results publication: PubMed 26025146Kelechi 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.
- Results publication: PubMed 16835515Hampton 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilüfer Kablan, PhD study director
University of Health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic drainage (MLD), Skin Care and Exercise in people with Venous Leg Ulcer and Venous Insufficiency, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04461132, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.