Ignite Creation Date:
2025-12-18 @ 8:24 AM
Ignite Modification Date:
2025-12-18 @ 8:24 AM
Study NCT ID:
NCT03783715
Status:
None
Last Update Posted:
2023-10-10 00:00:00
First Post:
2018-12-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Treatment Responses in Lymphedema
Sponsor:
None
Organization:
Study Overview
Official Title:
Characterization of Treatment Responses in Lymphedema
Status:
None
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was halted due to Covid-19 pandemic and unavailability of ketoprofen.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients presenting to the Investigator's Clinic for evaluation and treatment of (upper or lower extremity) lymphedema, will be assessed for their suitability (of low risk) for medical treatment with ketoprofen. If there are no contra-indications to taking ketoprofen, after discussion of FDA warnings, including provision of a written copy of the FDA language to the patient, and with the recommendation to discuss with the primary physician-of-record, patients will be provided with a prescription for ketoprofen 200 mg daily (one capsule taken orally, once daily) or if obtained from a compound pharmacy, ketoprofen 210 mg daily (one capsule taken orally, once daily).
Participation in this study will be offered. Two study visits, at baseline and month 6 are required. Measurements (circumferential and skin thickness) and a blood sample will be taken at each study visit.
The investigators will try to determine how ketoprofen affects the body tissue by obtaining blood samples and measurements, before starting treatment and at month 6.
Participation in this study will be offered. Two study visits, at baseline and month 6 are required. Measurements (circumferential and skin thickness) and a blood sample will be taken at each study visit.
The investigators will try to determine how ketoprofen affects the body tissue by obtaining blood samples and measurements, before starting treatment and at month 6.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: