Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer; Diabetic Foot; Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: DIAMEL; Dietary Supplement: Placebo

• Registration Number: NCT03583593
• Lead Sponsor: Catalysis SL

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

Not available

Study Timeline

• Study Start: 2014-05-23
• Primary Completion: 2017-11-12
• Study Completion: 2017-11-30
• Status Verified: 2018-06
• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-28
• Last Update Submitted: 2018-06-28
• Study First Posted: 2018-07-11
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population

Exclusion Criteria

• Manifestation of hypersensitivity to any component of the product
• Uncooperative patients
• Severe infection
• Debilitating diseases
• Steroid treatment
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIAMEL	DIAMEL	Study group that receives the active product.
Placebo	Placebo	Control group receiving double-blind placebo.

Primary Outcome Measures

Name	Time	Method
Time of healing	1 year	The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers.

Secondary Outcome Measures

Name	Time	Method
Glycemic control	1 year	Glucose measures with blood test
Insulin control	1 year	Insulin levels measured by the Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population
Lipidic control	1 year	Triglycerides and cholesterol levels with blood test
Body mass control	1 year	Body mass test
Renal function control	1 year	Renal function measures by Creatinine Clearance Blood Test

Trial Locations

Locations (1)

National Institute of Endocrinology; 🇨🇺 Vedado, Havana, Cuba