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Establishing Guidelines for Manual Lymphatic Drainage (MLD)

Primary Purpose

Lymphedema of Leg

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pressure
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Leg

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Light Tactile Pressure

Medium Tactile Pressure

Firm Tactile Pressure

Arm Description

light tactile pressure with 5-10 mmHg without skin stretch

medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position

firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 (%).
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 (%).
Change in Intracellular Fluid in liters
• Description: All fluid contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).
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 (%)
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 (%)
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 (%).
Change in Basal Metabolic Rate (BMR) in lbs
Daily amount of energy a person's body burns when at complete rest. Expressed in calories.
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.

Full Information

First Posted
July 24, 2022
Last Updated
May 16, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05509062
Brief Title
Establishing Guidelines for Manual Lymphatic Drainage
Acronym
MLD
Official Title
Establishing Guidelines for Manual Lymphatic Drainage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Leg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment Group 1 Treatment Group 2 Treatment Group 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Light Tactile Pressure
Arm Type
Active Comparator
Arm Description
light tactile pressure with 5-10 mmHg without skin stretch
Arm Title
Medium Tactile Pressure
Arm Type
Active Comparator
Arm Description
medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position
Arm Title
Firm Tactile Pressure
Arm Type
Active Comparator
Arm Description
firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift
Intervention Type
Procedure
Intervention Name(s)
Pressure
Intervention Description
Subjects are randomized to one of three treatment groups
Primary Outcome Measure Information:
Title
Change in The L-dex (Lymphedema Index).
Description
The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in Total body weight in liters
Description
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 (%).
Time Frame
18 Months
Title
Change in Extracellular Fluid in liters
Description
All fluid that is not contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).
Time Frame
18 months
Title
Change in Intracellular Fluid in liters
Description
• Description: All fluid contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).
Time Frame
18 Months
Title
Change in Skeletal Muscle Mass in lbs
Description
The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)
Time Frame
18 Months
Title
Change in Fat Mass in lbs
Description
The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)
Time Frame
18 Months
Title
Change in Free Fat Mass in lbs
Description
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 (%).
Time Frame
18 Months
Title
Change in Basal Metabolic Rate (BMR) in lbs
Description
Daily amount of energy a person's body burns when at complete rest. Expressed in calories.
Time Frame
18 Months
Title
Change in Basal Metabolic Rate in kg/m^2
Description
A relationship between weight and height that is associated with body fat and health risks. BMI = weight / height2.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nargis Kalia, MPH
Phone
303-724-7361
Email
nargis.kalia@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tracey MacDermott, BA BS CCRC
Phone
303-724-2757
Email
tracey.macdermott@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Del Chiaro
Organizational Affiliation
University of Colorado Denver | Anschutz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nargis Kalia, MPH
Phone
303-724-7361
Email
nargis.kalia@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Tracey MacDermott, BA BS CCRC
Phone
303-724-2757
Email
tracey.macdermott@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Christodoulos Kaoutzanis, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Establishing Guidelines for Manual Lymphatic Drainage

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