Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

NCT03583593 | Completed Phase 2 DMC

• 1 other identifier: DIAMEL-DIABETICFOOT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Diabetes; Insulin; Diabetic Foot; Nutritional supplement; Diamel

Outcome Measures

Primary Outcomes (1)

• Time of healing

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

  1 year

Secondary Outcomes (5)

• Glycemic control

  1 year

• Lipidic control

  1 year

• Body mass control

  1 year

• Renal function control

  1 year

• Insulin control

  1 year

Study Arms (2)

DIAMEL

EXPERIMENTAL

Study group that receives the active product.

Dietary Supplement: DIAMEL

Placebo

PLACEBO COMPARATOR

Control group receiving double-blind placebo.

Dietary Supplement: Placebo

Interventions

DIAMEL DIETARY_SUPPLEMENT

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

DIAMEL

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

National Institute of Endocrinology

Vedado, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: It is a double blind study, that is, neither the researcher nor the patient knows if he takes placebo or the active tablet.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 11, 2018
• Study Start: May 23, 2014
• Primary Completion: November 12, 2017
• Study Completion: November 30, 2017
• Last Updated: July 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU (1)