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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00477022
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : May 25, 2007
Information provided by:
Zahedan University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Vasotrain-447 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : February 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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, ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00477022

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00477022     History of Changes
Other Study ID Numbers: 86-456
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007
Keywords provided by Zahedan University of Medical Sciences:
Diabetic Foot Ulcer
Vacuum compression therapy
Ulcer Area
Random Controlled Trial.
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases