Diabetic Foot UlcersNCT01068171
Developing a Diabetic Foot Ulcer Protocol
A study testing type of footwear and collagen dressing with and without silver in people with Diabetic Foot Ulcers, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way. 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?
- type of footwear and collagen dressing with and without silver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult - over 18 years of age
- Diabetes with an A1c of less than or equal to 9% - if no A1c result is available within the past 3 months, one will be drawn to qualify the patient for the study
- No evidence of circulatory compromise
- Posterior tibial or pedal pulse present on palpation
- No pallor on elevation
- No dependent rubor
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- Loss of sensation on forefoot using monofilament
- Wound or callus on only 1 foot
- Wound Classification - Wagner Grade 1, non-infected
- Ulcer present for 1 - 3 months
- Ulcer of forefoot only
- No previous ulcer of that foot or amputation of either extremity
- Wound size < 1" diameter
- Wound bed pink
Who cannot join
- Diagnoses with unpredictable trajectory or healing ability, i.e.
- Psychiatric disorders
- Cancer
- ESRD not eligible for dialysis
- HIV
- Previous lower extremity amputation
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- Charcot foot
- Evidence of circulatory compromise
- Absence of pulses
- Decreased capillary refill (> 3 seconds)
- Trophic skin changes - shiny, hairless toes
- Ankle Brachial Index < 0.8
Trial locations and contacts
1 site in 1 country.
United States1 site
Harris County Hospital District Community Health
Houston, Texas, 77054
About this study
Official title: Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population
The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.
Read the detailed description
This pilot study will be conducted in Harris County Hospital District (HCHD) Community Health Centers and Wound Care Clinics.
The study will use random assignment of patients who meet inclusion criteria to: postoperative shoe with or without collagen; removable Air-boot with or without collagen; or monitored Air-boot with or without collagen. All treatment is standard of care.
Enrollment will occur at a clinic appointment. During the consent appointment, follow-up will be scheduled. Patients whose wound meets study criteria will be approached by a Podiatrist or therapist during a wound care visit. An A1c will be obtained, if not done within the past 3 months. A convenience sample will be drawn from people with diabetes, aged 18 or more, who meet inclusion criteria.
Frequency of visits will be:
- patients with monitored Air-boot: weekly
- all others: every 2 weeks At each visit there will be a dressing change, wound assessment and review of how many times shoe/boot was removed or not used during the preceding 1 or 2 weeks.
Should healing not occur within 6 months or the wound progress, the patient will be referred for evaluation of possible vascular involvement.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- type of footwear, collagen dressing with and without silver
- Keywords
- diabetes, foot ulcers, off-loading, collagen, Wagner 1
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type of footwearOther
Also called DJO XP Diabetic Walker, Camcon Medical postoperative shoe, Smith and Nephew Allevyn Foam dressing
comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored
collagen dressing with and without silverOther
Also called Smith & Nephew Biostep dressing with Allevyn Foam cover, Smith & Nephew Biostep Ag gressing with Allevyn Foam cover
silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months
| Study group | Role | What they receive |
|---|---|---|
| shoe, plain dressing | Active comparator | post-op shoe with plain occlusive dressing Receives: Other: type of footwear |
| shoe, collagen | Active comparator | post-op shoe with collagen dressing Receives: Other: collagen dressing with and without silver |
| boot, plain dressing | Active comparator | air boot with occlusive dressing Receives: Other: type of footwear |
| boot, collagen | Active comparator | air boot with collagen dressing Receives: Other: collagen dressing with and without silver |
| monitored air boot, plain dressing | Active comparator | air boot with retention strap to monitor whether boot is removed with occlusive dressing Receives: Other: type of footwear |
| monitored boot with collagen | Active comparator | air boot with retention strap to monitor whether boot is removed with collagen dressing Receives: Other: collagen dressing with and without silver |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in size of wound
Measured: 6 months
Secondary outcomes (1)
non-healing wound
Measured: 6 months or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012
Why it stopped: no patients who met enrollment criteria
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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Harris County Hospital District, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Gary Lepow, DPM, Principal investigator, University of Texas Health Science at Houston, Baylor College of MedicineTalar L Glover, MS, RN, CNS, Principal investigator, Harris County Hospital District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068171
- Sponsor's protocol ID
- HSC-GEN-09-0418
- Status last verified
- Nov 2020
- First submitted
- 11 Feb 2010
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population
- ClinicalTrials.gov ID
- NCT01068171
- Acronym / sponsor ID
- HSC-GEN-09-0418
- Conditions
- Diabetic Foot Ulcers
- Keywords
- diabetes, foot ulcers, off-loading, collagen, Wagner 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients who met enrollment criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Harris County Hospital District, Baylor College of Medicine
- Study start
- May 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Feb 2010 (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 purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.
Detailed description
This pilot study will be conducted in Harris County Hospital District (HCHD) Community Health Centers and Wound Care Clinics.
The study will use random assignment of patients who meet inclusion criteria to: postoperative shoe with or without collagen; removable Air-boot with or without collagen; or monitored Air-boot with or without collagen. All treatment is standard of care.
Enrollment will occur at a clinic appointment. During the consent appointment, follow-up will be scheduled. Patients whose wound meets study criteria will be approached by a Podiatrist or therapist during a wound care visit. An A1c will be obtained, if not done within the past 3 months. A convenience sample will be drawn from people with diabetes, aged 18 or more, who meet inclusion criteria.
Frequency of visits will be:
- patients with monitored Air-boot: weekly
- all others: every 2 weeks At each visit there will be a dressing change, wound assessment and review of how many times shoe/boot was removed or not used during the preceding 1 or 2 weeks.
Should healing not occur within 6 months or the wound progress, the patient will be referred for evaluation of possible vascular involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| shoe, plain dressing | Active comparator | Other: type of footwearpost-op shoe with plain occlusive dressing |
| shoe, collagen | Active comparator | Other: collagen dressing with and without silverpost-op shoe with collagen dressing |
| boot, plain dressing | Active comparator | Other: type of footwearair boot with occlusive dressing |
| boot, collagen | Active comparator | Other: collagen dressing with and without silverair boot with collagen dressing |
| monitored air boot, plain dressing | Active comparator | Other: type of footwearair boot with retention strap to monitor whether boot is removed with occlusive dressing |
| monitored boot with collagen | Active comparator | Other: collagen dressing with and without silverair boot with retention strap to monitor whether boot is removed with collagen dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult - over 18 years of age
- Diabetes with an A1c of less than or equal to 9% - if no A1c result is available within the past 3 months, one will be drawn to qualify the patient for the study
- No evidence of circulatory compromise
- Loss of sensation on forefoot using monofilament
- Wound or callus on only 1 foot
Key exclusion criteria (12 listed)
- Diagnoses with unpredictable trajectory or healing ability, i.e.
- Previous lower extremity amputation
- Charcot foot
- Evidence of circulatory compromise
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 |
|---|---|---|
| type of footwearAlso: DJO XP Diabetic Walker, Camcon Medical postoperative shoe, Smith and Nephew Allevyn Foam dressingcomparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored | Other | boot, plain dressing, monitored air boot, plain dressing, shoe, plain dressing |
| collagen dressing with and without silverAlso: Smith & Nephew Biostep dressing with Allevyn Foam cover, Smith & Nephew Biostep Ag gressing with Allevyn Foam coversilver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months | Other | boot, collagen, monitored boot with collagen, shoe, collagen |
Primary outcome
decrease in size of wound
Time frame: 6 months
1 secondary outcome
non-healing wound
Time frame: 6 months or less
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
Related trials for Diabetic Foot Ulcers
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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
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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.
Gary Lepow, DPM principal investigator
University of Texas Health Science at Houston, Baylor College of Medicine
Talar L Glover, MS, RN, CNS principal investigator
Harris County Hospital District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing type of footwear and collagen dressing with and without silver in people with Diabetic Foot Ulcers, run by The University of Texas Health Science Center, Houston 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?
The sponsor lists 14 inclusion and 12 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: withdrawn, as of the sponsor's last update on 5 Nov 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
decrease in size of wound (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 5 Nov 2020.