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

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vasotrain-447
Sponsored by
Zahedan University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Vacuum compression therapy, Stereology, Ulcer Area, Vasotrain, Random Controlled Trial.

Eligibility Criteria

45 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of physiotherapy, Zahedan university of medical scinces

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2007
Last Updated
May 22, 2007
Sponsor
Zahedan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00477022
Brief Title
The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers
Acronym
VCT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Zahedan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic Foot Ulcer, Vacuum compression therapy, Stereology, Ulcer Area, Vasotrain, Random Controlled Trial.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vasotrain-447
Primary Outcome Measure Information:
Title
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,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asghar Akbari, PhD
Organizational Affiliation
Deputy of research, Zahedan university of medical scinces
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of physiotherapy, Zahedan university of medical scinces
City
Zahedan
State/Province
Sistan & Bladchestan
ZIP/Postal Code
98136-64855
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
8438004
Citation
McCulloch JM Jr, Kemper CC. Vacuum-compression therapy for the treatment of an ischemic ulcer. Phys Ther. 1993 Mar;73(3):165-9. doi: 10.1093/ptj/73.3.165.
Results Reference
background
PubMed Identifier
17943674
Citation
Akbari A, Moodi H, Ghiasi F, Sagheb HM, Rashidi H. Effects of vacuum-compression therapy on healing of diabetic foot ulcers: randomized controlled trial. J Rehabil Res Dev. 2007;44(5):631-6. doi: 10.1682/jrrd.2007.01.0002.
Results Reference
derived
Links:
URL
http://www.diabetes.org
Description
Provides extensive news and information about diabetes including symptoms, nutrition, weight loss, prevention, research, and community resources

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

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