Partial Thickness WoundsPhase 2NCT00714519
Feasibility Study of the Execution of an Efficacy Trial in the Nursing Home Setting
A Phase 2 study testing Xenaderm® Ointment in people with Partial Thickness Wounds, run by Healthpoint.
Trial summary
This study will assess if a clinical trial regarding healing of partial thickness wounds can be executed in nursing homes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Thickness Wounds
- What is being tested?
- Xenaderm® Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Oct 2008
- 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
- Provide written informed consent, which consists of reading, signing and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. If the subject is unable to read or sign the informed consent, or unable to comprehend the information provided in the consent process, a legal guardian, decision making proxy, or next of kin must provide written consent, and if possible, subject must verbally assent to receiving an experimental treatment for their wound.
- Are at least 18 years of age.
- Are expected to remain in the Nursing Home for the duration of the study (22 days).
- Have one or more partial-thickness wounds (including wounds with excoriation, erosion or denuded skin, or ulceration to subcutaneous fat, but with no fascia, muscle, tendon or bone visible) on the trunk or proximal extremity (arm above the elbow, leg above the knee) which
- have been present for at least 2 days but less than 6 weeks;
- measure greater than or equal to 2 and less than or equal to40 cm2 in total denuded area; and,
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- are connected by areas of erythema (for multiple wounds).
- Are capable of maintaining an adequate nutritional intake during the study.
- Are in an acceptable state of health and nutrition with pre-albumin levels of greater than or equal to 15 mg/dl (0.015g/l), serum albumin greater than or equal to 3.0 g/dl (30g/l), alkaline phosphatase greater than or equal to the lower limit of normal, and have no abnormal laboratory values that, in the opinion of the Medical Supervisor, place the subject at risk for the study.
Who cannot join
- Have more than 64 cm2 of total denuded wound area, including target and non-target wounds.
- Have a full-thickness wound within 4 cm of any target wound.
- Have clinical evidence of bacterial or fungal infection of the target wound.
- Have target wound(s) that involves tunneling, sinus tracks, shear injury, arterial occlusive disease or bony prominence or joint with the exception that target wounds may be over dorsal spinous processes, coccyx, ischial tuberosities or sacroiliac joints (but may not be full thickness).
- Are moribund, or has a severe burn, immunodeficiency disorder, hematologic disorder, metastatic malignancy or uncontrolled diabetes mellitus.
- Are known to have acrodermatitis enteropathica (zinc deficiency).
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- Are being treated with systemic steroids, immunosuppressive agents, radiation or chemotherapy.
- Have been treated with enzymatic debridement to the target wound(s) within 2 days prior to enrollment.
- Have a known sensitivity to ingredients of Xenaderm Ointment.
- Are using or have used another investigational agent (not including devices such as hearing aids, pace makers, etc.) within 30 days prior to Visit 1.
About this study
Official title: A Phase II Feasibility Study of Xenaderm® Ointment Exploring Design Issues for Phase III Efficacy in Partial-Thickness Wounds
This study will assess if a clinical trial regarding healing of partial thickness wounds can be executed in nursing homes.
Read the detailed description
This study will test the efficacy of Xenaderm® vs. vehicle on the healing of partial thickness wounds caused by pressure, moisture and friction.
- Conditions
- Partial Thickness Wounds
- Being tested
- Xenaderm® Ointment, Placebo Comparator
- Keywords
- Xenaderm, partial, thickness, wounds, Nursing Homes
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenaderm® OintmentDrug
Also called Placebo Comparator
Topical, BID or as needed
Placebo ComparatorDrug
Also called Xenaderm® Ointment
Topical, BID or as needed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Xenaderm® Ointment |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
Measured: 21 days
Secondary outcomes (1)
Adverse Events
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: The study was terminated due to the inability to enroll subjects. No subjects were or ever will be enrolled into this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Thickness WoundsStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Herbert B Slade, MD, Study chair, HealthpointInnes Cargill, PhD, Study director, Healthpoint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714519
- Sponsor's protocol ID
- 011-101-09-032
- Status last verified
- Aug 2013
- First submitted
- 10 Jul 2008
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Feasibility Study of Xenaderm® Ointment Exploring Design Issues for Phase III Efficacy in Partial-Thickness Wounds
- ClinicalTrials.gov ID
- NCT00714519
- Acronym / sponsor ID
- 011-101-09-032
- Conditions
- Partial Thickness Wounds
- Keywords
- Xenaderm, partial, thickness, wounds, Nursing Homes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated due to the inability to enroll subjects. No subjects were or ever will be enrolled into this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Jul 2008 (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 study will assess if a clinical trial regarding healing of partial thickness wounds can be executed in nursing homes.
Detailed description
This study will test the efficacy of Xenaderm® vs. vehicle on the healing of partial thickness wounds caused by pressure, moisture and friction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Xenaderm® Ointment |
| 2 | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent, which consists of reading, signing and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. If the subject is unable to read or sign the informed consent, or unable to comprehend the information provided in the consent process, a legal guardian, decision making proxy, or next of kin must provide written consent, and if possible, subject must verbally assent to receiving an experimental treatment for their wound.
- Are at least 18 years of age.
- Are expected to remain in the Nursing Home for the duration of the study (22 days).
- Have one or more partial-thickness wounds (including wounds with excoriation, erosion or denuded skin, or ulceration to subcutaneous fat, but with no fascia, muscle, tendon or bone visible) on the trunk or proximal extremity (arm above the elbow, leg above the knee) which
- Are capable of maintaining an adequate nutritional intake during the study.
Key exclusion criteria (10 listed)
- Have more than 64 cm2 of total denuded wound area, including target and non-target wounds.
- Have a full-thickness wound within 4 cm of any target wound.
- Have clinical evidence of bacterial or fungal infection of the target wound.
- Have target wound(s) that involves tunneling, sinus tracks, shear injury, arterial occlusive disease or bony prominence or joint with the exception that target wounds may be over dorsal spinous processes, coccyx, ischial tuberosities or sacroiliac joints (but may not be full thickness).
- Are moribund, or has a severe burn, immunodeficiency disorder, hematologic disorder, metastatic malignancy or uncontrolled diabetes mellitus.
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 |
|---|---|---|
| Xenaderm® OintmentAlso: Placebo ComparatorTopical, BID or as needed | Drug | 1 |
| Placebo ComparatorAlso: Xenaderm® OintmentTopical, BID or as needed | Drug | 2 |
Primary outcome
Complete Wound Closure
Time frame: 21 days
1 secondary outcome
Adverse Events
Time frame: 21 days
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 30 Aug 2013.
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Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
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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.
Herbert B Slade, MD study chair
Healthpoint
Innes Cargill, PhD study director
Healthpoint
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xenaderm® Ointment in people with Partial Thickness Wounds, run by Healthpoint.
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 9 inclusion and 10 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 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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?
Complete Wound Closure (time frame: 21 days). 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 30 Aug 2013.