The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers (VCT)

May 22, 2007 updated by: Zahedan University of Medical Sciences

the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri's principle in diabetic patients.

Study Overview

Status

Completed

Conditions

Diabetic Foot Ulcer

Intervention / Treatment

Device: Vasotrain-447

Detailed Description

Diabetic foot ulcers are common and serious complications of chronic diabetes mellitus. The prevalence of foot ulcers among patients with diabetes is 15%. The length of hospital stay is approximately 60% longer among patients with foot ulcers, as compared with those without ulcers. Diabetic foot ulcers accounts for >50% of all nontraumatic lower-leg amputations.Although, current preventive methods and treatment modalities have been effective in healing foot ulcers, statistics show high incidence of foot ulcers and amputations in individuals with diabetes.On the other hand, only a few studies were performed on the effects of Vasotrain in healing diabetic foot ulcers. The use of the machine enhances the delivery of oxygen and nutrients to the area, which in turn, facilitate wound healing

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Iran, Islamic Republic of
- Sistan & Bladchestan
  - Zahedan, Sistan & Bladchestan, Iran, Islamic Republic of, 98136-64855
    - Dept. of physiotherapy, Zahedan university of medical scinces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

A diabetic foot ulcer corresponding to grade 2
No history of deep venous thrombosis and no hemorrhage in ulcer

Exclusion Criteria:

Significant loss of protective sensation
Hemorrhage during treatment
Vertigo
No completion of treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Foot ulcer surface area was estimated stereologically, based on Cavalieri's principle before and after intervention, at pre treatment and post treatment Time Frame: Baseline, 3 Weeks,	Baseline, 3 Weeks,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zahedan University of Medical Sciences

Investigators

Principal Investigator: Asghar Akbari, PhD, Deputy of research, Zahedan university of medical scinces

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Provides extensive news and information about diabetes including symptoms, nutrition, weight loss, prevention, research, and community resources

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria