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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03583593
Other study ID # DIAMEL-DIABETICFOOT
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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