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NCT Number: NCT00477022

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

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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

45 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of physiotherapy, Zahedan university of medical scinces

Zahedan, Sistan & Bladchestan, 98136-64855, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasotrain-447

Device

Primary outcomes

  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,

Sponsors and collaborators

Lead sponsor

Zahedan University of Medical Sciences

Other

Registry information

Acronym: VCT

Important dates

Study start
2006
Study completion
2006
First posted
May 22, 2007
Registry last updated
May 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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