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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00477022
Acronym
VCT
Enrollment
20
Registered
2007-05-22
Start date
2006-02-28
Completion date
2006-11-30
Last updated
2007-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer, Vacuum compression therapy, Stereology, Ulcer Area, Vasotrain, Random Controlled Trial.

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

Interventions

DEVICEVasotrain-447

Sponsors

Zahedan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
45 Years to 69 Years
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

Design outcomes

Primary

MeasureTime frame
Foot ulcer surface area was estimated stereologically, based on Cavalieri's principle before and after intervention, at pre treatment and post treatmentBaseline, 3 Weeks,

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026