Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583593
• Other study ID #: DIAMEL-DIABETICFOOT
• Status: Completed
• Phase: Phase 2
• Start date: May 23, 2014
• Est. completion date: November 30, 2017

Study information

• Verified date: June 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2017
• Est. primary completion date: November 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• DIAMEL
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
• Placebo
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.

Locations

Country	Name	City	State
Cuba	National Institute of Endocrinology	Vedado	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glycemic control	Glucose measures with blood test	1 year
Secondary	Lipidic control	Triglycerides and cholesterol levels with blood test	1 year
Secondary	Body mass control	Body mass test	1 year
Secondary	Renal function control	Renal function measures by Creatinine Clearance Blood Test	1 year
Secondary	Insulin control	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	1 year