A Phase 2 interventional study of DIAMEL and Placebo in Diabetic Foot Ulcer, Diabetic Foot and Diabetes Mellitus, Type 2, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Catalysis SL · Phase 2, Interventional, and Supportive care
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study group that receives the active product.
Dietary Supplement: DIAMEL
Control group receiving double-blind placebo.
Dietary Supplement: Placebo
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.
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.
Time frame: 1 year
Glycemic control
Glucose measures with blood test
Time frame: 1 year
Lipidic control
Triglycerides and cholesterol levels with blood test
Time frame: 1 year
Body mass control
Body mass test
Time frame: 1 year
Renal function control
Renal function measures by Creatinine Clearance Blood Test
Time frame: 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
Time frame: 1 year
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Ran from May 2014 to primary completion in Nov 2017, 41 months.
Of 31 phase 2 interventional studies under Diabetic Foot, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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