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

NCT ID: NCT00477022

Last Updated: 2007-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-11-30

Brief Summary

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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

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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

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Vasotrain-447

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zahedan University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Asghar Akbari, PhD

Role: PRINCIPAL_INVESTIGATOR

Deputy of research, Zahedan university of medical scinces

Locations

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Dept. of physiotherapy, Zahedan university of medical scinces

Zahedan, Sistan & Bladchestan, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 8438004 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17943674 (View on PubMed)

Related Links

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http://www.diabetes.org

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

Other Identifiers

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86-456

Identifier Type: -

Identifier Source: org_study_id