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Trial registered on ANZCTR


Registration number
ACTRN12610000565044
Ethics application status
Approved
Date submitted
9/07/2010
Date registered
13/07/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Clinical Trial for Treatment of Diabetic Foot Ulcers with Dietary Nano-formulated Phytochemicals
Scientific title
Pilot Clinical Trial for Treatment of Diabetic Foot Ulcers with Dietary Nano-formulated Phytochemicals in Mediterranean and Middle eastern Males suffering from Type 2 Diabetes with diabetic foot syndrome.
Secondary ID [1] 252191 0
none
Universal Trial Number (UTN)
U1111-1115-9694
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic foot ulcers 257719 0
Condition category
Condition code
Metabolic and Endocrine 257884 257884 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
to study the effect of dietary supplementation with Soy Isoflavones, Lycopene, Resveratrol, Gingerol Sage, Rosmarine and Curcumine and their combinations on diabetic foot ulcers in patients with type 2 diabetes. The study product is to be administered once daily, by mouth, with the evening meal in a hard gelatin capsule for a sixty day period. The gelatin capsule contains the recommended therapeutic dosage(based on subject inclusion criterion of weight 60-80kg) of oral lactolycopene, Lactolycopene/LaFlavon, Resveratrol, Gingerol, Curcume, Sage and Rosemarine.
Intervention code [1] 256775 0
Treatment: Other
Comparator / control treatment
single group assignment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258756 0
regression of diabetic ulcer rate in this patient population with an associated increased plasma level of phytochemicals (Lycopene, Soy Isoflavones, Resveratrol, Gingerol, Curcume, Sage, Rosemarine and their combinations) after daily intake of nano-formulated capsules/tablets for sixty days by assessing morphometry of the ulcer and by utilizing the foot pressure study.
Timepoint [1] 258756 0
timeframe- 60 days after beginning treatment
Secondary outcome [1] 264808 0
Increased plasma concentration of phytochemicals (Lycopene, Soy Isoflavones, resveratrol, Gingerol, Curcume,Sage, Rosemarine and their combinations) after daily intake of a single phytochemical capsule in patients with diabetic foot syndrome measured by blood sample at baseline and at the two month conclusion of the trial.
Timepoint [1] 264808 0
timeframe- 60 days after treatment initiation
Secondary outcome [2] 264809 0
reduction and/or elimination of pyo-necrotic complication in the ulcers by assessing serum and urine concentrations of creatinine, protein, Tumor Necrosis Factor-alpha antibody,( TNF-a).
Timepoint [2] 264809 0
timeframe- 60 days after treatment initiation
Secondary outcome [3] 264810 0
reduction of c-reactive protein (CRP) and degree of granulocytosis via blood hematology and chemistry assessment of these factors.
Timepoint [3] 264810 0
timeframe- 60 days after treatment initiation
Secondary outcome [4] 264811 0
reduction of low-density lipoprotein (LDL) and plasma lipids (cholesterol and triglycerides) via serum chemistry evaluation.
Timepoint [4] 264811 0
timeframe- 60 days after treatment initiation
Secondary outcome [5] 264812 0
reduction of plasma fibrinogen level via chemistry analysis of serum sample.
Timepoint [5] 264812 0
timeframe- 60 days after treatment initiation
Secondary outcome [6] 264813 0
improved rate of foot pressure test using the barefoot plantar foot pressure test at baseline and at the two month conclusion of the study.
Timepoint [6] 264813 0
timeframe- 60 days after treatment initiation
Secondary outcome [7] 264814 0
reduction of cytokine levels in the discharge from diabetic ulcers will be assessed by collecting 100 microliters of serous discharge and performing assay for cytokines.
Timepoint [7] 264814 0
timeframe- 60 days after treatment initiation

Eligibility
Key inclusion criteria
Mediterranean and Middle Eastern males, age 18-65 (inclusive) suffering from Type 2 Diabetes with diabetic foot syndrome (1 and 2 grade Wagner scale) with body weight between 60-80 kg.

Stable metabolic and glycemic control during last three months of disease and during trial period.


Foot ulcer aged at least two weeks sized 0.5-2.0 cm.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Any foot ulceration not related to type 2 diabetes

Diabetic foot syndrome graded above 2 on Wagner's scale.

Kidney abnormalities requiring medical intervention.

Infectious complications of diabetic foot syndrome.

Critical abnormalities of blood circulation in affected limb.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 2753 0
Egypt
State/province [1] 2753 0

Funding & Sponsors
Funding source category [1] 257266 0
Commercial sector/Industry
Name [1] 257266 0
Cambridge Theranostics, ltd.
Country [1] 257266 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
CamMedica, Ltd.
Address
Brook House
Tarrington
Herefordshire
HR1 4EU
United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 256510 0
None
Name [1] 256510 0
Address [1] 256510 0
Country [1] 256510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259287 0
Ethics Committee, Faculty of Medicine, Alexandria University
Ethics committee address [1] 259287 0
Alexandria University
165 El-Horreya Avenue
El-Hadra postal code 21561
Alexandria, Egypt
Ethics committee country [1] 259287 0
Egypt
Date submitted for ethics approval [1] 259287 0
Approval date [1] 259287 0
05/03/2010
Ethics approval number [1] 259287 0
030692

Summary
Brief summary
This study is designed to evaluate the potential benefit of dietary supplementation of phytochemicals (lycopene, soy isoflavones, resveratrol, gingerol, curcume Rosmarine and their combinations) on diabetic foot syndrome in patients with type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31374 0
Address 31374 0
Country 31374 0
Phone 31374 0
Fax 31374 0
Email 31374 0
Contact person for public queries
Name 14621 0
Regina Silver, RN, BA
Address 14621 0
95 Rockland Street
Swampscott, Ma.
USA 01907
Country 14621 0
United States of America
Phone 14621 0
00 +1 781-462-8539
Fax 14621 0
Email 14621 0
[email protected]
Contact person for scientific queries
Name 5549 0
Yuriy Bashmakov, M.D.
Address 5549 0
Cambridge Theranostics
Babraham Research Campus
Babraham
Cambridge
CB22 3AT, UK
Country 5549 0
United Kingdom
Phone 5549 0
+44 797-159-8348
Fax 5549 0
Email 5549 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.