Pilot Clinical Trial for Treatment of Diabetic Foot Ulcers with Dietary Nano-formulated Phytochemicals

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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000565044

Enrollment

Registered

2010-07-13

Start date

2010-07-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, Lactolycope

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Healthy volunteers

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.

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.

Outcome results