NCT00477022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
Last Updated

May 25, 2007

Status Verified

May 1, 2007

First QC Date

May 21, 2007

Last Update Submit

May 22, 2007

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot UlcerVacuum compression therapyStereologyUlcer AreaVasotrainRandom Controlled Trial.

Outcome Measures

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

    Baseline, 3 Weeks,

Interventions

Vasotrain-447DEVICE

Eligibility Criteria

Age45 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diabetic foot ulcer corresponding to grade 2
  • No history of deep venous thrombosis and no hemorrhage in ulcer

You may not qualify if:

  • Significant loss of protective sensation
  • Hemorrhage during treatment
  • Vertigo
  • No completion of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of physiotherapy, Zahedan university of medical scinces

Zahedan, Sistan & Bladchestan, 98136-64855, Iran

Location

Related Publications (2)

  • 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.

    PMID: 8438004BACKGROUND

  • 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.

    PMID: 17943674DERIVED

Related Links

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Asghar Akbari, PhD

    Deputy of research, Zahedan university of medical scinces

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

February 1, 2006

Study Completion

November 1, 2006

Last Updated

May 25, 2007

Record last verified: 2007-05

Locations

IR(1)