---
title: Establishing Guidelines for Manual Lymphatic Drainage
nct_id: NCT05509062
overall_status: COMPLETED
phase: NA
sponsor: University of Colorado, Denver
study_type: INTERVENTIONAL
primary_condition: Lymphedema of Leg
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05509062.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05509062"
ct_last_update_post_date: 2024-01-11
last_seen_at: "2026-05-12T07:00:50.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Establishing Guidelines for Manual Lymphatic Drainage

**NCT ID:** [NCT05509062](https://clinicaltrials.gov/study/NCT05509062)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** University of Colorado, Denver
- **Conditions:** Lymphedema of Leg
- **Start Date:** 2022-07-20
- **Completion Date:** 2023-04-30
- **CT.gov Last Update:** 2024-01-11

## 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.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Light Tactile Pressure** (ACTIVE_COMPARATOR) — light tactile pressure with 5-10 mmHg without skin stretch
- **Medium Tactile Pressure** (ACTIVE_COMPARATOR) — medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position
- **Firm Tactile Pressure** (ACTIVE_COMPARATOR) — firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift

## Interventions

- **Pressure** (PROCEDURE) — Subjects are randomized to one of three treatment groups

## Primary Outcomes

- **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

- **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)_

## Locations (1)

- University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of colorado anschutz medical campus|aurora|colorado|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05509062.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05509062*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*