Lymphedema of LegMLDNCT05509062
Establishing Guidelines for Manual Lymphatic Drainage
A study testing Pressure in people with Lymphedema of Leg, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Lymphedema of Leg
- What is being tested?
- Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 30 Apr 2023
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults between the age of 30 - 75 years
- Lower extremity lymphedema
Who cannot join
- Pregnant women
- Participants who are unable to stand independently for up to 2 mins
- Participants who cannot make their own decisions
- Participants undergoing cancer treatment
- Participants with an Infection (active cellulitis)
- Participants with a known Iodine Allergy
Show all 10Show fewer
- Participants who weigh more than 375 lbs
- Participants with cardiac arrhythmias or implanted electronic equipment
- Participants who have undergone joint replacement in involved extremity
- Participants with cardiac insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.
Read the detailed description
To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift.
- Conditions
- Lymphedema of Leg
- Being tested
- Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PressureProcedure or surgery
Subjects are randomized to one of three treatment groups
| Study group | Role | What they receive |
|---|---|---|
| Light Tactile Pressure | Active comparator | light tactile pressure with 5-10 mmHg without skin stretch Receives: Procedure: Pressure |
| Medium Tactile Pressure | Active comparator | medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position Receives: Procedure: Pressure |
| Firm Tactile Pressure | Active comparator | firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift Receives: Procedure: Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The L-dex (Lymphedema Index).
The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.
Measured: 18 months
Secondary outcomes (8)
Change in Total body weight in liters
All the water within a person's body, including both intracellular and extracellular fluid. Expressed as volume (liters or pints) and percentage of total weight (%).
Measured: 18 Months
Change in Extracellular Fluid in liters
All fluid that is not contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).
Measured: 18 months
Change in Intracellular Fluid in liters
- Description: All fluid contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).
Measured: 18 Months
Change in Skeletal Muscle Mass in lbs
The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)
Measured: 18 Months
Change in Fat Mass in lbs
The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)
Measured: 18 Months
Change in Free Fat Mass in lbs
The amount of mass a person has that contains no fat (lean body mass). Includes muscle, connective tissue, organs, body water and bone. Expressed in kgs or lbs and percentage of total weight (%).
Measured: 18 Months
Change in Basal Metabolic Rate (BMR) in lbs
Daily amount of energy a person's body burns when at complete rest. Expressed in calories.
Measured: 18 Months
Change in Basal Metabolic Rate in kg/m^2
A relationship between weight and height that is associated with body fat and health risks. BMI = weight / height2.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start20 Jul 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of LegStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Treatment Group 1 Treatment Group 2 Treatment Group 3
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Del Chiaro, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509062
- Sponsor's protocol ID
- 22-0733
- Acronym
- MLD
- Status last verified
- Jan 2024
- First submitted
- 24 Jul 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Guidelines for Manual Lymphatic Drainage
- ClinicalTrials.gov ID
- NCT05509062
- Acronym / sponsor ID
- MLD / 22-0733
- Conditions
- Lymphedema of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Aug 2022 (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.
The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.
Detailed description
To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Treatment Group 1 Treatment Group 2 Treatment Group 3
| Arm | Type | Receives |
|---|---|---|
| Light Tactile Pressure | Active comparator | Procedure: Pressurelight tactile pressure with 5-10 mmHg without skin stretch |
| Medium Tactile Pressure | Active comparator | Procedure: Pressuremedium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position |
| Firm Tactile Pressure | Active comparator | Procedure: Pressurefirm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adults between the age of 30 - 75 years
- Lower extremity lymphedema
Key exclusion criteria (10 listed)
- Pregnant women
- Participants who are unable to stand independently for up to 2 mins
- Participants who cannot make their own decisions
- Participants undergoing cancer treatment
- Participants with an Infection (active cellulitis)
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 |
|---|---|---|
| PressureSubjects are randomized to one of three treatment groups | Procedure or surgery | Firm Tactile Pressure, Light Tactile Pressure, Medium Tactile Pressure |
Primary outcome
Change in The L-dex (Lymphedema Index).
Time frame: 18 months
The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.
8 secondary outcomes
Change in Total body weight in liters
Time frame: 18 Months
Change in Extracellular Fluid in liters
Time frame: 18 months
Change in Intracellular Fluid in liters
Time frame: 18 Months
Change in Skeletal Muscle Mass in lbs
Time frame: 18 Months
Change in Fat Mass in lbs
Time frame: 18 Months
Change in Free Fat Mass in lbs
Time frame: 18 Months
Change in Basal Metabolic Rate (BMR) in lbs
Time frame: 18 Months
Change in Basal Metabolic Rate in kg/m^2
Time frame: 18 months
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 11 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Marco Del Chiaro principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure in people with Lymphedema of Leg, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 10 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 11 Jan 2024. 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 United States. 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. 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?
Change in The L-dex (Lymphedema Index). (time frame: 18 months). 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 11 Jan 2024.