Trial · NCT02257970

Lymphedema Study for Arm or Leg Lymphedema

NCT02257970, Phase 4, Completed, Stanford University; results first posted 2018-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lymphedema Study for Arm or Leg Lymphedema. Trials, record NCT02257970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02257970

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lymphedema Study for Arm or Leg Lymphedema
NCT number: NCT02257970
Status: Completed
Phases: Phase 4
Enrollment: 117 participants, actual
Lead sponsor: Stanford University
Conditions: Lymphedema
Interventions: Ketoprofen, Placebo
First posted: 2014-10-07
Last updated: 2022-10-27
Results first posted: 2018-09-14

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Part 1: Count of Participants Able to Complete Ketoprofen Treatment	Baseline to month 6	Participants who were able to complete ketoprofen treatment and experienced no treatment-related serious adverse events.
Primary	Part 2: Change From Baseline in Cutaneous Histological Architecture	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.
Primary	Part 3: Measurement of Skin Thickness	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	Part 2: Measurement of Skin Thickness	Baseline and 4 months	Caliper measured skin thickness (mm) of lymphedema-affected limb was serially assessed and pre-to-post paired analysis was performed.
Secondary	Part 3: Change From Baseline in Cutaneous Histological Architecture	Baseline; 4 months	Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen or placebo, respectively. 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. For the analysis, the 4-month post-minus-pre change in this score for ketoprofen- and placebo-recipients, respectively, was compared. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology.
Secondary	Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy	Baseline; 4 months	A four-electrode configuration was used to non-invasively assess the extracellular and intracellular fluid contents of the limb. Data were analyzed according to Cole theory, using the manufacturer's software (Impedimed Ltd.), to provide values for a bioimpedance ratio (Ro), the resistance of the extracellular fluid including lymph, R∞ the resistance of total tissue fluid and Ri, the resistance of the intracellular fluid. For the purposes of these investigations, in patients with unilateral lymphedema, the ratio of Ro in the affected:unaffected limbs was analyzed in each patient, as a measure of the bioimpedance attributable to the extracellular fluid content. An Ro level of 1.034 was considered normal; values ≥1.034 were considered abnormal.
Secondary	Part 2/Part 3: Change in Limb Volume	Baseline; 4 months	Quantitative assessment of limb volume (ml) of the affected limb at study end compared to pre-treatment values.
Secondary	Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)	Baseline; 4 months	The systemic inflammatory response of G-CSF, in the two treatment groups, Ketoprofen and Placebo, will be assessed with Luminex-bead inflammasome analysis of pre- and post-treatment plasma samples. G-CSF, a glycoprotein, is an inflammatory cytokine produced by endothelium and immune cells. Ketoprofen is a unique NSAID possessing dual pathways of inflammatory inhibition, blocking cyclooxygenase (COX) and 5-LO. Measurement using median fluorescence intensity (MFI) was employed.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part 1: Count of Participants Able to Complete Ketoprofen Treatment	Baseline to month 6	This outcome was assessed in Part 1 participants only.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Part 2: Change From Baseline in Cutaneous Histological Architecture	Baseline; Month 4	This primary endpoint outcome was assessed in Part 2 participants only.	score on a scale	MEAN
PRIMARY	Part 3: Measurement of Skin Thickness	Baseline and 4 months	Data for this outcome were collected in Part 3 participants only and for lymphedema-affected limbs only.	mm	MEAN
SECONDARY	Part 2: Measurement of Skin Thickness	Baseline and 4 months	Data for this outcome were collected in Part 2 participants only and for lymphedema-affected limbs only.	mm	MEAN
SECONDARY	Part 3: Change From Baseline in Cutaneous Histological Architecture	Baseline; 4 months	Data for this outcome were collected in Part 3 participants only and for lymphedema tissue samples only.	score on a scale	MEAN
SECONDARY	Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy	Baseline; 4 months	Data for this outcome were collected for Part 2 and Part 3 participants with unilateral lymphedema-affected limbs only.	ratio of Ro values	MEAN
SECONDARY	Part 2/Part 3: Change in Limb Volume	Baseline; 4 months	Data for this outcome were collected only for lymphedema-affected limbs only.	ml	MEAN
SECONDARY	Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)	Baseline; 4 months	Data for this outcome was collected for Part 3 participants only.	MFI (log10)	MEAN

Source ClinicalTrials.gov

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Part 1: Count of Participants Able to Complete Ketoprofen Treatment	Part 1: Exploratory Group		50		Participants
Part 2: Change From Baseline in Cutaneous Histological Architecture	Part 2: Open-label Group	Baseline	6.125	Standard Deviation 2.247	score on a scale
Part 2: Change From Baseline in Cutaneous Histological Architecture	Part 2: Unaffected Tissue Samples	Baseline	0.8	Standard Deviation 1.2	score on a scale
Part 2: Change From Baseline in Cutaneous Histological Architecture	Part 2: Open-label Group	Month 4	2.688	Standard Deviation 1.401	score on a scale
Part 2: Change From Baseline in Cutaneous Histological Architecture	Part 2: Unaffected Tissue Samples	Month 4	0.6	Standard Deviation 1.0	score on a scale
Part 3: Measurement of Skin Thickness	Part 3: Placebo Group	Baseline	47	Standard Deviation 28	mm
Part 3: Measurement of Skin Thickness	Part 3: Ketoprofen Group	Baseline	49	Standard Deviation 21	mm
Part 3: Measurement of Skin Thickness	Part 3: Placebo Group	Month 4	45	Standard Deviation 31	mm
Part 3: Measurement of Skin Thickness	Part 3: Ketoprofen Group	Month 4	41	Standard Deviation 21	mm
Part 2: Measurement of Skin Thickness	Part 2: Open-label Group	Baseline	62	Standard Deviation 34	mm

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Part 1	STARTED	Part 1: Exploratory Group	50
Part 1	STARTED	Part 2: Open-label Group	0
Part 1	STARTED	Part 3: Placebo Group	0
Part 1	STARTED	Part 3: Ketoprofen Group	0
Part 1	COMPLETED	Part 1: Exploratory Group	50
Part 1	COMPLETED	Part 2: Open-label Group	0
Part 1	COMPLETED	Part 3: Placebo Group	0
Part 1	COMPLETED	Part 3: Ketoprofen Group	0
Part 1	NOT COMPLETED	Part 1: Exploratory Group	0
Part 1	NOT COMPLETED	Part 2: Open-label Group	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cellulitis	Skin and subcutaneous tissue disorders	Part 1: Exploratory Group	3	50	3
other	Cellulitis	Skin and subcutaneous tissue disorders	Part 2: Open-label Group	1	23	1
other	Cellulitis	Skin and subcutaneous tissue disorders	Part 3: Placebo Group	0	23	0
other	Cellulitis	Skin and subcutaneous tissue disorders	Part 3: Ketoprofen Group	0	21	0
other	Rash	Skin and subcutaneous tissue disorders	Part 1: Exploratory Group	0	50	0
other	Rash	Skin and subcutaneous tissue disorders	Part 2: Open-label Group	1	23	1
other	Rash	Skin and subcutaneous tissue disorders	Part 3: Placebo Group	1	23	1
other	Rash	Skin and subcutaneous tissue disorders	Part 3: Ketoprofen Group	1	19	1
other	Hemorrhoidal hemorrhag	Gastrointestinal disorders	Part 1: Exploratory Group	0	50	0
other	Hemorrhoidal hemorrhag	Gastrointestinal disorders	Part 2: Open-label Group	0	23	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1: Exploratory Group	0	50
Total, all-cause mortality	Part 2: Open-label Group	0	23
Total, all-cause mortality	Part 3: Placebo Group	0	23
Total, all-cause mortality	Part 3: Ketoprofen Group	0	21
Total, other adverse events	Part 1: Exploratory Group	3	50
Total, other adverse events	Part 2: Open-label Group	2	23
Total, other adverse events	Part 3: Placebo Group	1	23
Total, other adverse events	Part 3: Ketoprofen Group	2	21
Total, serious adverse events	Part 1: Exploratory Group	0	50
Total, serious adverse events	Part 2: Open-label Group	0	23

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30333315	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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