Diabetic Foot UlcerVCTNCT00477022
The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers
A study testing Vasotrain-447 in people with Diabetic Foot Ulcer, run by Zahedan University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 45 to 69 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Vasotrain-447
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Feb 2006to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diabetic foot ulcer corresponding to grade 2
- No history of deep venous thrombosis and no hemorrhage in ulcer
Who cannot join
- Significant loss of protective sensation
- Hemorrhage during treatment
- Vertigo
- No completion of treatment
Trial locations and contacts
1 site in 1 country.
Iran1 site
Dept. of physiotherapy, Zahedan university of medical scinces
Zahedan, Sistan & Bladchestan, 98136-64855
About this study
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.
Read the 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
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Vasotrain-447
- Keywords
- Diabetic Foot Ulcer, Vacuum compression therapy, Stereology, Ulcer Area, Vasotrain, Random Controlled Trial.
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasotrain-447Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot ulcer surface area was estimated stereologically, based on Cavalieri's principle before and after intervention, at pre treatment and post treatment
Measured: Baseline, 3 Weeks,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startFeb 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Asghar Akbari, PhD, Principal investigator, Deputy of research, Zahedan university of medical scinces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477022
- Sponsor's protocol ID
- 86-456
- Acronym
- VCT
- Status last verified
- May 2007
- First submitted
- 21 May 2007
- Last updated
- 25 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8438004Akbari 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.
PubMed 17943674
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00477022
- Acronym / sponsor ID
- VCT / 86-456
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Vacuum compression therapy, Stereology, Ulcer Area, Vasotrain, Random Controlled Trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diabetic foot ulcer corresponding to grade 2
- No history of deep venous thrombosis and no hemorrhage in ulcer
Key exclusion criteria (4 listed)
- Significant loss of protective sensation
- Hemorrhage during treatment
- Vertigo
- No completion of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasotrain-447 | Device | – |
Primary outcome
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2007.
- Background: PubMed 8438004McCulloch 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.
- Derived from this study: PubMed 17943674Akbari 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.
- Provides extensive news and information about diabetes including symptoms, nutrition, weight loss, prevention, research, and community resourcesLink provided by the sponsor.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asghar Akbari, PhD principal investigator
Deputy of research, Zahedan university of medical scinces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasotrain-447 in people with Diabetic Foot Ulcer, run by Zahedan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00477022, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2007.