Diabetic Foot UlcersPhase 2NCT00013299
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
A Phase 2 study testing Prevention of Diabetic Ulcers in people with Diabetic Foot Ulcers, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Prevention of Diabetic Ulcers
- Type of treatment
- Medical device
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Apr 2001
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Diabetics with foot ulcerations
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.
Read the detailed description
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Prevention of Diabetic Ulcers
- Keywords
- Foot ulcers, amputation prevention, diabetes, footwear, insoles
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention of Diabetic UlcersDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study startOct 2000
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 427 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- John Fryer, Ph.D. Asst. Director, Program Analysis and Review Section (PARS), Rehabilitation Research & Development ServiceWijegupta Ellepola, Program Analyst, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013299
- Sponsor's protocol ID
- A2443R
- Status last verified
- Jan 2001
- First submitted
- 14 Mar 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
- ClinicalTrials.gov ID
- NCT00013299
- Acronym / sponsor ID
- A2443R
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Foot ulcers, amputation prevention, diabetes, footwear, insoles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2000
- Study completion
- Apr 2001 (actual)
- First posted
- 16 Mar 2001 (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.
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.
Detailed description
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Prevention of Diabetic Ulcers | Device | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
Related trials for Diabetic Foot Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
John Fryer, Ph.D. Asst. Director
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Wijegupta Ellepola, Program Analyst
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prevention of Diabetic Ulcers in people with Diabetic Foot Ulcers, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jan 2009. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 21 Jan 2009.