Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-03 @ 8:20 PM
Study NCT ID:
NCT03583593
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2018-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Sponsor:
Catalysis SL
Organization:
Study Overview
Official Title:
Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: