Diabetic Foot UlcerPhase 2NCT03583593
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
A Phase 2 study testing DIAMEL in people with Diabetic Foot Ulcer and Diabetic Foot, run by Catalysis SL at 1 site in Cuba.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot, Diabetes Mellitus, Type 2
- What is being tested?
- DIAMEL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCuba
- Study dates
- 23 May 2014to 30 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population
Who cannot join
- Manifestation of hypersensitivity to any component of the product
- Uncooperative patients
- Severe infection
- Debilitating diseases
- Steroid treatment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
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.
- Being tested
- DIAMEL, Placebo
- Keywords
- Diabetes, Insulin, Diabetic Foot, Nutritional supplement, Diamel
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAMELDietary supplement
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
PlaceboDietary supplement
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.
| Study group | Role | What they receive |
|---|---|---|
| DIAMEL | Experimental | Study group that receives the active product. Receives: Dietary Supplement: DIAMEL |
| Placebo | Placebo comparator | Control group receiving double-blind placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Glycemic control
Glucose measures with blood test
Measured: 1 year
Lipidic control
Triglycerides and cholesterol levels with blood test
Measured: 1 year
Body mass control
Body mass test
Measured: 1 year
Renal function control
Renal function measures by Creatinine Clearance Blood Test
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start23 May 2014
- Primary completion12 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583593
- Sponsor's protocol ID
- DIAMEL-DIABETICFOOT
- Status last verified
- Jun 2018
- First submitted
- 15 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT03583593
- Acronym / sponsor ID
- DIAMEL-DIABETICFOOT
- Keywords
- Diabetes, Insulin, Diabetic Foot, Nutritional supplement, Diamel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 23 May 2014 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIAMEL | Experimental | Dietary Supplement: DIAMELStudy group that receives the active product. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboControl group receiving double-blind placebo. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population
Key exclusion criteria (6 listed)
- Manifestation of hypersensitivity to any component of the product
- Uncooperative patients
- Severe infection
- Debilitating diseases
- Steroid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIAMELDiamel is administered 6 capsules a day divided into three doses that are ingested before each meal. | Dietary supplement | DIAMEL |
| PlaceboPlacebo is administered 6 capsules a day divided into three doses that are ingested before each meal. | Dietary supplement | Placebo |
Primary outcome
Time of healing
Time frame: 1 year
The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers.
5 secondary outcomes
Glycemic control
Time frame: 1 year
Lipidic control
Time frame: 1 year
Body mass control
Time frame: 1 year
Renal function control
Time frame: 1 year
Insulin control
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Yes
Related trials for Diabetic Foot Ulcer
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DIAMEL in people with Diabetic Foot Ulcer and Diabetic Foot, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of healing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.