Lower Limb LymphedemaNCT05996939
Use of the Unstable Shoes in Lower Limb Lymphedema.
A study testing To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema. in people with Lower Limb Lymphedema, run by Universidad Europea de Madrid.
Trial summary
Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph transport. It is defined as accumulation in the extracellular space of protein-rich fluid, due to a mechanical failure of the lymphatic system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Lymphedema
- What is being tested?
- To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 30 Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Subjects affected with lower limb lymphedema -primary, secondary, unilateral or bilateral-, -Daily use of a compression stocking
Who cannot join
- Subjects with acute infection of the affected limb
- that did not had any treatment for lymphedema one year prior to the study,
- Weight <40kg,
- shoe size <EU35 or >EU47
- that have previously used unstable shoes
- vestibular alterations, vertigo, hypoacusis
- visual compromise that affects balanc
About this study
Official title: Effectiveness of Unstable Shoes on Volume and Quality of Life in Lower Limb Lymphedema.
Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph transport. It is defined as accumulation in the extracellular space of protein-rich fluid, due to a mechanical failure of the lymphatic system. Lymphedema directly affects the quality of life of the patient, not only in the physical aspect, but also in the psychological, sexual and social aspects. Muscle and joint pumps are important external mechanisms of lymphatic and venous fluid return improvement. The unstable shoes demands, especially during standing, increased muscle activity in the lower extremities. A clinical trial was carried out comparing both kinds of footwear, the objective being to evaluate possible differences in the evolution of lymphedema. Unstable shoes (MBT®) were compared with conventional sports shoes. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema. The results suggested that the use of unstable shoes is recommendable for walking and for long periods of standing, since it decreases leg cramping and paraesthesia of affected limbs.
Read the detailed description
Participants Subjects were recruited amongst the members of a Spanish association of people affected with lymphedema. Inclusion criteria were a) Subjects affected with lower limb lymphedema -primary, secondary, unilateral or bilateral-, b) Daily use of a compression stocking. Exclusion criteria were a) Subjects with acute infection of the affected limb b) that did not had any treatment for lymphedema one year prior to the study, c) Weight <40kg, d) shoe size <EU35 or >EU47 e)that have previously used unstable shoes f) vestibular alterations, vertigo, hypoacusis c) visual compromise that affects balance.
Procedure Written informed consent was obtained from the participants before the intervention. Random allocation to experimental and control group, was performed using Excel built-in function RAND ().. The generated sequence was employed to allocate the participants to one of the trial groups (e.g., intervention or control). Participants followed an 8 week intervention. Experimental group (EG) were provided with unstable sole shoes (MBT®, Masai Barefoot Technology Spain SL,08021 Spain.) and asked to wear them following a standardized protocol: 1 hour on day 1, increasing 1h each 2 days until 4h of daily use are achieved, during standing position and walking in the context of daily live activities, excluding sport activities. Control group (CG) was provided with a conventional sole sports footwear, following the same protocol that EG.
Outcome measures Circumferencial measure. Circumferencial measure was evaluated using a tape measure to measure the circumference of the foot at different points. Distal (4 cm from the base of the nail towards proximal) and Proximal (4 cm from the previous measurement).
Volume. Kuhnke's formula was used to calculate the estimated volume of the affected limb(241) V=(C12 + C22 +… Cn2)/π, Where V represents the volume and C refers to the different diameters of the limb, measured in centimeters.
Perception of the participants' clinical manifestations (243): measured through a questionnaire on perception of the state of the person's vascular alteration referred to the affected limb. In this survey, the subject is asked to value their symptoms (included heaviness, spider veins, swelling, pain, appearance of varicose veins, cramps, paresthesia and venous ulcers) with a 4-point scale: 0=absent, 1=mild/moderate, 2=important, 3=severe. In addition to lower limb swelling, other important symptoms experienced are heaviness, tightness, and pain. As there is no validated scale or survey to measure these symptoms characteristic of lymphedema, we used as a reference a previous study [10], where the symptoms or clinical manifestations compatible with chronic venous insufficiency that can be extrapolated to lymphedema are described.
In addition, a Change of habits survey was conducted at the end of the intervention period
- Conditions
- Lower Limb Lymphedema
- Being tested
- To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.Other
Unstable shoes were compared with conventional sports shoes, the objective being to evaluate possible differences in the evolution of lymphedema. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema.
| Study group | Role | What they receive |
|---|---|---|
| Unstable shoes | Experimental | Use of unstable shoes for 8 weeks Receives: Other: To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema. |
| Usual sports footwear | No intervention | Use of conventional shoes for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of the lower limb
Volume of the lower limb
Measured: 8 weeks
Secondary outcomes (2)
Circumference measure of the foot
Circumference measure of the foot
Measured: 8 weeks
Changes in lymphedema symptoms
Changes in lymphedema symptoms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Nov 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb LymphedemaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanesa Abuín, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996939
- Sponsor's protocol ID
- UEM_LIN_2011_01
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Unstable Shoes on Volume and Quality of Life in Lower Limb Lymphedema.
- ClinicalTrials.gov ID
- NCT05996939
- Acronym / sponsor ID
- UEM_LIN_2011_01
- Conditions
- Lower Limb Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Aug 2023 (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.
Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph transport. It is defined as accumulation in the extracellular space of protein-rich fluid, due to a mechanical failure of the lymphatic system. Lymphedema directly affects the quality of life of the patient, not only in the physical aspect, but also in the psychological, sexual and social aspects. Muscle and joint pumps are important external mechanisms of lymphatic and venous fluid return improvement. The unstable shoes demands, especially during standing, increased muscle activity in the lower extremities. A clinical trial was carried out comparing both kinds of footwear, the objective being to evaluate possible differences in the evolution of lymphedema. Unstable shoes (MBT®) were compared with conventional sports shoes. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema. The results suggested that the use of unstable shoes is recommendable for walking and for long periods of standing, since it decreases leg cramping and paraesthesia of affected limbs.
Detailed description
Participants Subjects were recruited amongst the members of a Spanish association of people affected with lymphedema. Inclusion criteria were a) Subjects affected with lower limb lymphedema -primary, secondary, unilateral or bilateral-, b) Daily use of a compression stocking. Exclusion criteria were a) Subjects with acute infection of the affected limb b) that did not had any treatment for lymphedema one year prior to the study, c) Weight <40kg, d) shoe size <EU35 or >EU47 e)that have previously used unstable shoes f) vestibular alterations, vertigo, hypoacusis c) visual compromise that affects balance.
Procedure Written informed consent was obtained from the participants before the intervention. Random allocation to experimental and control group, was performed using Excel built-in function RAND ().. The generated sequence was employed to allocate the participants to one of the trial groups (e.g., intervention or control). Participants followed an 8 week intervention. Experimental group (EG) were provided with unstable sole shoes (MBT®, Masai Barefoot Technology Spain SL,08021 Spain.) and asked to wear them following a standardized protocol: 1 hour on day 1, increasing 1h each 2 days until 4h of daily use are achieved, during standing position and walking in the context of daily live activities, excluding sport activities. Control group (CG) was provided with a conventional sole sports footwear, following the same protocol that EG.
Outcome measures Circumferencial measure. Circumferencial measure was evaluated using a tape measure to measure the circumference of the foot at different points. Distal (4 cm from the base of the nail towards proximal) and Proximal (4 cm from the previous measurement).
Volume. Kuhnke's formula was used to calculate the estimated volume of the affected limb(241) V=(C12 + C22 +… Cn2)/π, Where V represents the volume and C refers to the different diameters of the limb, measured in centimeters.
Perception of the participants' clinical manifestations (243): measured through a questionnaire on perception of the state of the person's vascular alteration referred to the affected limb. In this survey, the subject is asked to value their symptoms (included heaviness, spider veins, swelling, pain, appearance of varicose veins, cramps, paresthesia and venous ulcers) with a 4-point scale: 0=absent, 1=mild/moderate, 2=important, 3=severe. In addition to lower limb swelling, other important symptoms experienced are heaviness, tightness, and pain. As there is no validated scale or survey to measure these symptoms characteristic of lymphedema, we used as a reference a previous study [10], where the symptoms or clinical manifestations compatible with chronic venous insufficiency that can be extrapolated to lymphedema are described.
In addition, a Change of habits survey was conducted at the end of the intervention period
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstable shoes | Experimental | Other: To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.Use of unstable shoes for 8 weeks |
| Usual sports footwear | No intervention | –Use of conventional shoes for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Subjects affected with lower limb lymphedema -primary, secondary, unilateral or bilateral-, -Daily use of a compression stocking
Key exclusion criteria (7 listed)
- Subjects with acute infection of the affected limb
- that did not had any treatment for lymphedema one year prior to the study,
- Weight <40kg,
- shoe size <EU35 or >EU47
- that have previously used unstable shoes
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 |
|---|---|---|
| To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.Unstable shoes were compared with conventional sports shoes, the objective being to evaluate possible differences in the evolution of lymphedema. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema. | Other | Unstable shoes |
Primary outcome
Volume of the lower limb
Time frame: 8 weeks
Volume of the lower limb
2 secondary outcomes
Circumference measure of the foot
Time frame: 8 weeks
Changes in lymphedema symptoms
Time frame: 8 weeks
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 18 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema. in people with Lower Limb Lymphedema, run by Universidad Europea de Madrid.
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 1 inclusion and 7 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Volume of the lower limb (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2023.