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Completed

NCT Number: NCT05509062

Establishing Guidelines for Manual Lymphatic Drainage

The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.

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Key information

Conditions

Lymphedema of Leg

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All adults between the age of 30 - 75 years
  • Lower extremity lymphedema

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Pressure

Procedure

Subjects are randomized to one of three treatment groups

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Total body weight in liters

    Time frame: 18 Months

    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 (%).

  2. Change in Extracellular Fluid in liters

    Time frame: 18 months

    All fluid that is not contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).

  3. Change in Intracellular Fluid in liters

    Time frame: 18 Months

    • Description: All fluid contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).

  4. Change in Skeletal Muscle Mass in lbs

    Time frame: 18 Months

    The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)

  5. Change in Fat Mass in lbs

    Time frame: 18 Months

    The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)

  6. Change in Free Fat Mass in lbs

    Time frame: 18 Months

    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 (%).

  7. Change in Basal Metabolic Rate (BMR) in lbs

    Time frame: 18 Months

    Daily amount of energy a person's body burns when at complete rest. Expressed in calories.

  8. Change in Basal Metabolic Rate in kg/m^2

    Time frame: 18 months

    A relationship between weight and height that is associated with body fat and health risks. BMI = weight / height2.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: MLD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2022
Registry last updated
Jan 11, 2024

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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