---
title: Lymphedema Study for Arm or Leg Lymphedema
nct_id: NCT02257970
overall_status: COMPLETED
phase: PHASE4
sponsor: Stanford University
study_type: INTERVENTIONAL
primary_condition: Lymphedema
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02257970.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02257970"
ct_last_update_post_date: 2022-10-27
last_seen_at: "2026-05-12T06:18:53.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Lymphedema Study for Arm or Leg Lymphedema

**Official Title:** Placebo-controlled, Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.

**NCT ID:** [NCT02257970](https://clinicaltrials.gov/study/NCT02257970)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 117
- **Lead Sponsor:** Stanford University
- **Conditions:** Lymphedema
- **Start Date:** 2009-03
- **Completion Date:** 2017-03
- **CT.gov Last Update:** 2022-10-27

## Brief Summary

This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.

## Detailed Description

Part 1 is feasibility, exploratory, open-label study of ketoprofen, to document effects.

Part 2, is open-label trial of ketoprofen to document histological response. Part 3 is double-blind randomized trial of receive placebo or ketoprofen to evaluate safety and efficacy.

We will try to determine how the study drug affects the body tissue by obtaining tissue biopsies (small pieces of skin from the arm or leg) before treatment and after treatment.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of \> 6 months.

Exclusion Criteria:

* Patients with active cancer, infection or bleeding tendency will be excluded.
* We will also exclude patients with medical contraindications to NSAIDs, including history of allergies, know gastrointestinal intolerance, or other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate.
* Minors (\<18 years of age) \*\>90 years of age
```

## Arms

- **Part 1: Exploratory Group** (EXPERIMENTAL) — Ketoprofen 225-300 mgs daily, taken orally

Ketoprofen-exploratory group: 225-300 mgs daily for four to six months
- **Part 2: Open-label Group** (EXPERIMENTAL) — Ketoprofen 225 mg daily, taken orally

Open-label group: 75 mgs, three times daily, for four months
- **Part 3: Placebo Group** (PLACEBO_COMPARATOR) — Participants randomized to receive placebo: placebo, three times daily, taken orally

Placebo: 1 capsule, three times daily, for four months
- **Part 3: Ketoprofen Group** (ACTIVE_COMPARATOR) — Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally

Ketoprofen: 1 capsule, three times daily, for four months

## Interventions

- **Ketoprofen** (DRUG)
- **Placebo** (DRUG) — Placebo to match ketoprofen.

## Primary Outcomes

- **Part 1: Count of Participants Able to Complete Ketoprofen Treatment** _(time frame: Baseline to month 6)_ — Participants who were able to complete ketoprofen treatment and experienced no treatment-related serious adverse events.
- **Part 2: Change From Baseline in Cutaneous Histological Architecture** _(time frame: Baseline; Month 4)_ — Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen. The impact of treatment on cutaneous histopathology was evaluated through the use of an empirically-derived scoring system (comprised of dermal thickness, intercellular mucin content, deep dermal collagen content, and perivascular infiltrate); this quantitative assessment was developed and performed by a dermatopathologist. Each characteristic was weighted equally and each specimen was assigned a cumulative subscale score of 0-5. The scores were summed for a total score (range: 0-20) which is presented here. Higher scores indicate a higher degree of pathology. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology.
- **Part 3: Measurement of Skin Thickness** _(time frame: Baseline and 4 months)_ — Caliper-measured skin thickness (mm) was serially assessed and pre-to-post paired analysis was performed for both arms (Placebo and Ketoprofen) of the study.

## Secondary Outcomes

- **Part 2: Measurement of Skin Thickness** _(time frame: Baseline and 4 months)_
- **Part 3: Change From Baseline in Cutaneous Histological Architecture** _(time frame: Baseline; 4 months)_
- **Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy** _(time frame: Baseline; 4 months)_
- **Part 2/Part 3: Change in Limb Volume** _(time frame: Baseline; 4 months)_
- **Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)** _(time frame: Baseline; 4 months)_

## Locations (1)

- Stanford University, Stanford, California, United States

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — 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.stanford university|stanford|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02257970.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02257970*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*