Foot UlcerPhase 2KC-002PTNCT00330265
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
A Phase 2 study testing KC-002 and Conventional Wound Therapy in people with Foot Ulcer and Diabetes, run by KeraCure at 21 sites in United States.
Trial summary
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetes
- What is being tested?
- KC-002 and Conventional Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2006to Sep 2009
- 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
Who may be able to join
- Participants included in the study must:
- Have Type 1 or Type 2 diabetes mellitus
- Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study
- Be able to visit the study doctor regularly for 24 weeks
Who cannot join
- Participants may not be included if:
- The diabetic foot ulcer is infected
- They have poor circulation in their study foot
- Cannot or will not wear a special boot to take pressure off the study ulcer
- They have certain other diseases or laboratory values which are not within a specified range
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites, 21 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
410-601-5106
- Recruiting
Preston Family Building
Boston, Massachusetts, 02118
617-414-6840
- Recruiting
Pharmaceutical Research Organization
Bountiful, Utah, 84010
801-294-9911
- Recruiting
Medical Associates
Clinton, Iowa, 52732
563-519-1871
- Recruiting
St. Vincent Health Center Wound Clinic
Erie, Pennsylvania, 16444
814-452-7878
- Recruiting
Roy Kroeker, DPM
Fresno, California, 93710
559-436-8162
- Recruiting
Foot Healthcare Associates, PC
Livonia, Michigan, 48152
734-542-9305
- Recruiting
Felix Sigal, DPM
Los Angeles, California, 90010
888-860-4325
- Recruiting
Institute for Advanced Wound Care at Baptist Medical Center South
Montgomery, Alabama, 36111
334-286-3444
- Recruiting
North American Center for Limb Preservation
New Haven, Connecticut, 06515
203-397-0624
- Recruiting
HOPE Research Institute
Phoenix, Arizona, 85050
602-274-4100
- Recruiting
San Antonio Podiatry Associates, PC
San Antonio, Texas, 78229
210-949-0807
- Recruiting
Bay Area Foot Care
San Francisco, California, 94115
415-292-0638
- Recruiting
Pivotal Clinical Research
Souderton, Pennsylvania, 18964
215-723-7121
- Recruiting
Doctor's Research Network
South Miami, Florida, 33143
305-662-1444
- Recruiting
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, 84770
435-688-5281
- Recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
520-792-1450
- Recruiting
Warren General Hospital Wound Clinic
Warren, Pennsylvania, 16365
814-723-3300 ext. 2752
- Recruiting
Georgetown University / Wound Healing Center
Washington D.C., District of Columbia, 20007
202-444-1784
- Recruiting
Central Washington Podiatry Service
Yakima, Washington, 98902
509-248-2900
- Recruiting
Martin Foot and Ankle
York, Pennsylvania, 17403
717-718-0216
About this study
Official title: A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study.
Participation in the study is for 24 weeks.
- Conditions
- Foot Ulcer, Diabetes
- Being tested
- KC-002, Conventional Wound Therapy
- Medical subject headings
- Foot Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC-002Device
Determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
Conventional Wound TherapyOther
Normal Saline Dressings
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | KC-002 Receives: Device: KC-002 |
| 2 | Other | Conventional Wound Therapy Receives: Other: Conventional Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KeraCure
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330265
- Sponsor's protocol ID
- NCT 20051320
- Acronym
- KC-002PT
- Status last verified
- Aug 2008
- First submitted
- 24 May 2006
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00330265
- Acronym / sponsor ID
- KC-002PT / NCT 20051320
- Conditions
- Foot Ulcer, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- KeraCureIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 26 May 2006 (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 determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study.
Participation in the study is for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: KC-002KC-002 |
| 2 | Other | Other: Conventional Wound TherapyConventional Wound Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have Type 1 or Type 2 diabetes mellitus
- Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study
- Be able to visit the study doctor regularly for 24 weeks
Key exclusion criteria (5 listed)
- The diabetic foot ulcer is infected
- They have poor circulation in their study foot
- Cannot or will not wear a special boot to take pressure off the study ulcer
- They have certain other diseases or laboratory values which are not within a specified range
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 |
|---|---|---|
| KC-002Determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus. | Device | 1 |
| Conventional Wound TherapyNormal Saline Dressings | Other | 2 |
Primary outcome
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2008.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KC-002 and Conventional Wound Therapy in people with Foot Ulcer and Diabetes, run by KeraCure at 21 sites 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M Meek (866-537-2287, clinicaltrial@keracure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment (time frame: 12 weeks). 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 26 Aug 2008.