Back to resultsEvaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Primary Purpose
Diabetic Foot Ulcer, Diabetic Foot, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
DIAMEL
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Foot Ulcer focused on measuring Diabetes, Insulin, Diabetic Foot, Nutritional supplement, Diamel
Eligibility Criteria
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
Sites / Locations
- National Institute of Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DIAMEL
Placebo
Arm Description
Study group that receives the active product.
Control group receiving double-blind placebo.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Glycemic control
Glucose measures with blood test
Lipidic control
Triglycerides and cholesterol levels with blood test
Body mass control
Body mass test
Renal function control
Renal function measures by Creatinine Clearance Blood Test
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03583593
Brief Title
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Official Title
Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2014 (Actual)
Primary Completion Date
November 12, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Diabetic Foot, Diabetes Mellitus, Type 2
Keywords
Diabetes, Insulin, Diabetic Foot, Nutritional supplement, Diamel
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
It is a double blind study, that is, neither the researcher nor the patient knows if he takes placebo or the active tablet.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DIAMEL
Arm Type
Experimental
Arm Description
Study group that receives the active product.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control group receiving double-blind placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
DIAMEL
Intervention Description
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.
Primary Outcome Measure Information:
Title
Time of healing
Description
The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Glycemic control
Description
Glucose measures with blood test
Time Frame
1 year
Title
Lipidic control
Description
Triglycerides and cholesterol levels with blood test
Time Frame
1 year
Title
Body mass control
Description
Body mass test
Time Frame
1 year
Title
Renal function control
Description
Renal function measures by Creatinine Clearance Blood Test
Time Frame
1 year
Title
Insulin control
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Institute of Endocrinology
City
Vedado
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
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