Evaluation of DIAMEL® Combined With Insulin in Diabetic F... | NCT03583593

Studies
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

NCT03583593

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

Jul 11, 2018Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Diabetic Foot Ulcer
Diabetic Foot
Diabetes Mellitus, Type 2

Interventions

DIAMEL
Placebo

Countries

Cuba

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2014Actual

Primary Completion Date

Nov 12, 2017Actual

Completion Date

Nov 30, 2017Actual

First Submitted Date

Jun 15, 2018

First Submission Date that Met QC Criteria

Jun 28, 2018

First Posted Date

Jul 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2018

Last Update Posted Date

Jul 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DIAMEL	Experimental	Study group that receives the active product.	Dietary Supplement: DIAMEL
Placebo	Placebo Comparator	Control group receiving double-blind placebo.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DIAMEL	Dietary Supplement	Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.	DIAMEL

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Glycemic control	Glucose measures with blood test	1 year
Lipidic control	Triglycerides and cholesterol levels with blood test	1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Endocrinology		Vedado	La Habana	10400	Cuba

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided