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NCT00477022 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

— VCT  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00477022
Other study ID # 86-456
Secondary ID
Status Completed
Phase N/A
First received May 21, 2007
Last updated May 22, 2007
Start date February 2006
Est. completion date November 2006

Study information
Verified date May 2007
Source Zahedan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 69 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Vasotrain-447

Locations
Country Name City State
Iran, Islamic Republic of Dept. of physiotherapy, Zahedan university of medical scinces Zahedan Sistan & Bladchestan

Sponsors (1)
Lead Sponsor Collaborator
Zahedan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

McCulloch JM Jr, Kemper CC. Vacuum-compression therapy for the treatment of an ischemic ulcer. Phys Ther. 1993 Mar;73(3):165-9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Foot ulcer surface area was estimated stereologically, based on Cavalieri’s principle before and after intervention, at pre treatment and post treatment Baseline, 3 Weeks,
See also
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Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A

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