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Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

NCT03583593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-11

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot
  • Diabetes Mellitus, Type 2

Interventions

DIETARY_SUPPLEMENT

DIAMEL

Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.

DIETARY_SUPPLEMENT

Placebo

Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-23
Primary Completion
2017-11-12
Completion
2017-11-30

Countries

  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583593 on ClinicalTrials.gov