Diabetic Foot UlcerPhase 3NCT00368693
Efficacy and Safety Study of Dermal-Living Skin Replacement to Treat Diabetic Foot Ulcers
A Phase 3 study testing Dermal - Living Skin Replacement (Dermal-LSR) in people with Diabetic Foot Ulcer, run by University of California, Davis at 2 sites in United States.
Trial summary
The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Dermal - Living Skin Replacement (Dermal-LSR)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Sep 2007
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have Type I or Type II diabetes
- Signed informed consent obtained from subject or legal guardian/representative prior to the first study intervention.
- Age ≥ 18 and < 85 years old at the time the informed consent is signed.
- Subjects will have a diabetic ulcer on the lower extremity, with the ulcer having all of the following characteristics:
- Full-thickness plantar ulcers (fore and mid foot only);
- Non-infected as determined by clinical assessment;
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- Neuropathic as determined by monofilament assessment;
- Area ≥ 1.0 cm2 ≤ 25.0 cm2 post-debridement;
- Has been present for at least 8 weeks under a physician's observation at the time of enrollment;
- Extends through the dermis but without tendon, muscle, capsule or bone exposure.
- Subjects will have only one diabetic foot ulcer on the target limb.
- Subjects will have either insulin-dependent or non-insulin-dependent diabetes mellitus (Type I or Type II, respectively) with a HbA1C value in the range of 6% to 12%.
- The ulcer bed at the time of enrollment must be free of all necrotic and infected soft and bony tissue as determined by clinical examination (no evidence of probing to bone) and by X-ray films.
- Ankle-brachial systolic pressure index between 0.7 and 1.3. If the value is > 1.3, then a transcutaneous partial pressure of oxygen (TcPO2) of ≥ 40 mmHg OR a toe pressure of ≥ 50 mmHg must be obtained for subject to be eligible.
- Female subjects must have a negative serum pregnancy test prior to the first treatment.
Who cannot join
- Known or suspected disease of the immune system currently under investigation, other than Diabetes Mellitus.
- Active or untreated malignancy or active, uncontrolled connective tissue disease.
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or corticosteroids less than 30 days before enrollment.
- Presence of necrosis, purulence or sinus tracts that cannot be removed by treatment.
- Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment.
- Active febrile illness (fever ≥ 38.0 ºC p.o.).
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- Renal or liver impairment as indicated by serum creatinine levels and liver function tests three or more times higher than the normal values.
- Osteomyelitis diagnosed by exposed bone and by radiological investigations.
- Subject has an active Charcot as determined by the clinical examination (new local pain, evidence of swelling and warmth).
- Subjects who refuse or who are unable to participate in all screening procedures, or to comply with the requirements of the study.
- Use of other investigational products at the time of enrollment or during the study.
- The use of any topical treatments, other than SOC, in or on the surface of the target ulcer at the time of enrollment.
- Subjects who have been enrolled in any investigational clinical trial within 30 days of the screening visit.
- Currently pregnant or lactating, or planning a pregnancy to occur during the study period.
- Known allergic reactions, including dermatological hypersensitivity, to any study product components.
- Recent or current history of alcohol or drug abuse.
- Subjects who, in the opinion of the Investigator, represent poor medical, psychological or psychiatric risks for whom therapy with an investigational product would be unwise.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Medical Center
Mather, California, 95655
University of California, Davis Medical Center Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Pivotal Study to Evaluate the Efficacy and Safety of Dermal - Living Skin Replacement (Dermal - LSR) in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot ulcers.
Read the detailed description
This prospective, randomized, controlled, open-label, multi-center study will test the efficacy of Dermal - Living Skin Replacement (Dermal - LSR) plus standard of care treatment against solely the standard of care treatment on participants with diabetic foot ulcers.
The purpose of this study is to test Dermal - LSR combined with standard treatment. We want to see how well it works and the number and types of side effects, if any. We hope to learn more about how to heal diabetic foot ulcers better.
You will:
- be interviewed and examined
- have weekly clinic visits
- have blood drawn
- have the ulcer photographed
- wear a walking boot to reduce pressure on the ulcer
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dermal - Living Skin Replacement (Dermal-LSR)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal - Living Skin Replacement (Dermal-LSR)Device
The only experimental procedure is the application of the study device, Dermal - Living Skin Replacement (Dermal - LSR), to the foot ulcer. All others are regular or standard procedures. Dermal - LSR is a gel containing living human skin cells. This gel is applied directly to ulcers to help repair the skin. The cells used in this study device have come from one foreskin (skin covering the tip of the penis) taken from a baby boy shortly after his birth for reasons unrelated to this study. All cells that will be used have been tested to be healthy and safe. The amount of the study device you will receive depends on the size of your ulcer at each treatment visit. You will receive less than a 1/4 teaspoon of Dermal - LSR for about every dime-size area of your ulcer as measured and calculated by the research investigator.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ulcer closure will be defined as complete re-epithelialization without the presence of any callus and/or exudate.
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 posted25 Aug 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: Study terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roslyn R Isseroff, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368693
- Sponsor's protocol ID
- Apopharma RS03-2004
- Other IDs
- VA File #05-08-00364
- Status last verified
- Apr 2015
- First submitted
- 24 Aug 2006
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Evaluate the Efficacy and Safety of Dermal - Living Skin Replacement (Dermal - LSR) in the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00368693
- Acronym / sponsor ID
- Apopharma RS03-2004
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low enrollment.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 25 Aug 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 purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot ulcers.
Detailed description
This prospective, randomized, controlled, open-label, multi-center study will test the efficacy of Dermal - Living Skin Replacement (Dermal - LSR) plus standard of care treatment against solely the standard of care treatment on participants with diabetic foot ulcers.
The purpose of this study is to test Dermal - LSR combined with standard treatment. We want to see how well it works and the number and types of side effects, if any. We hope to learn more about how to heal diabetic foot ulcers better.
You will:
- be interviewed and examined
- have weekly clinic visits
- have blood drawn
- have the ulcer photographed
- wear a walking boot to reduce pressure on the ulcer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Have Type I or Type II diabetes
- Signed informed consent obtained from subject or legal guardian/representative prior to the first study intervention.
- Age ≥ 18 and < 85 years old at the time the informed consent is signed.
- Subjects will have a diabetic ulcer on the lower extremity, with the ulcer having all of the following characteristics:
- Subjects will have only one diabetic foot ulcer on the target limb.
Key exclusion criteria (17 listed)
- Known or suspected disease of the immune system currently under investigation, other than Diabetes Mellitus.
- Active or untreated malignancy or active, uncontrolled connective tissue disease.
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or corticosteroids less than 30 days before enrollment.
- Presence of necrosis, purulence or sinus tracts that cannot be removed by treatment.
- Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment.
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 |
|---|---|---|
| Dermal - Living Skin Replacement (Dermal-LSR)The only experimental procedure is the application of the study device, Dermal - Living Skin Replacement (Dermal - LSR), to the foot ulcer. All others are regular or standard procedures. Dermal - LSR is a gel containing living human skin cells. This gel is applied directly to ulcers to help repair the skin. The cells used in this study device have come from one foreskin (skin covering the tip of the penis) taken from a baby boy shortly after his birth for reasons unrelated to this study. All cells that will be used have been tested to be healthy and safe. The amount of the study device you will receive depends on the size of your ulcer at each treatment visit. You will receive less than a 1/4 teaspoon of Dermal - LSR for about every dime-size area of your ulcer as measured and calculated by the research investigator. | Device | – |
Primary outcome
Complete ulcer closure will be defined as complete re-epithelialization without the presence of any callus and/or exudate.
Time frame: 12 Weeks
Results and safety
The study was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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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.
Roslyn R Isseroff, M.D. principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dermal - Living Skin Replacement (Dermal-LSR) in people with Diabetic Foot Ulcer, run by University of California, Davis at 2 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 15 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.
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?
Complete ulcer closure will be defined as complete re-epithelialization without the presence of any callus and/or exudate. (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 7 Apr 2015.