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

This study has been completed.
Sponsor:
Information provided by:
Zahedan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00477022
First received: May 21, 2007
Last updated: May 22, 2007
Last verified: May 2007
History of Changes
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcer
 Device: Vasotrain-447

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zahedan University of Medical Sciences:

Primary Outcome Measures:
  • 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, ]

Enrollment: 20
Study Start Date: February 2006
Study Completion Date: November 2006
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

  Eligibility

Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477022

Locations
Iran, Islamic Republic of
Dept. of physiotherapy, Zahedan university of medical scinces
Zahedan, Sistan & Bladchestan, Iran, Islamic Republic of, 98136-64855
Sponsors and Collaborators
Zahedan University of Medical Sciences
Investigators
Principal Investigator: Asghar Akbari, PhD Deputy of research, Zahedan university of medical scinces
  More Information

Additional Information:
Provides extensive news and information about diabetes including symptoms, nutrition, weight loss, prevention, research, and community resources  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00477022     History of Changes
Other Study ID Numbers: 86-456
Study First Received: May 21, 2007
Last Updated: May 22, 2007
Health Authority: Iran: Ethics Committee

Keywords provided by Zahedan University of Medical Sciences:
Diabetic Foot Ulcer
Vacuum compression therapy
Stereology
 Ulcer Area
Vasotrain
Random Controlled Trial.

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 21, 2013