Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: DIAMEL
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIAMEL<br>Study group that receives the active product. | Dietary Supplement: DIAMEL<br>* Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.<br>|
| Placebo Comparator: Placebo<br>Control group receiving double-blind placebo. | Dietary Supplement: Placebo<br>* Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glucose measures with blood test | 1 year | 
| Lipidic control | Triglycerides and cholesterol levels with blood test | 1 year | 
| Body mass control | Body mass test | 1 year | 
| Renal function control | Renal function measures by Creatinine Clearance Blood Test | 1 year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin, Diabetic Foot, Nutritional supplement, Diamel