Diabetes MellitusPhase 3NCT00959595
Improvement of Sensibility in the Foot in Diabetic Patients Induced by EMLA-application to the Lower Leg
A Phase 3 study testing EMLA cream in people with Diabetes Mellitus, run by Lund University Hospital at 1 site in Sweden.
Trial summary
Sensory input from the foot as well as all other body parts results in activation of sensory cortex. It is well known that the cortical body map is experienced-dependant and can rapidly change in response to changes in activity and sensory input from the periphery [10-12]. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- EMLA cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2008to Jan 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-75 years) suffering from diabetes with subjective sensory impairment in the sole of the foot.
Who cannot join
- Patients with painful neuropathy or established ulcer formation in toes or sole of the foot, known hypersensitivity to local anaesthetics, major vascular reconstructions, communication problems due to severe language problems.
- Patients with pacemakers or magnetic implants or suffering from claustrophobia will not be subjected to fMRI-investigation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Hand Surgery, Malmö University Hospital
Malmö, SE-205 02
About this study
Official title: Improvement of Sensibility in the Sole of the Foot in Diabetic Patients, Induced by EMLA-application to the Lower Leg - a Double Blind Study
Sensory input from the foot as well as all other body parts results in activation of sensory cortex.
It is well known that the cortical body map is experienced-dependant and can rapidly change in response to changes in activity and sensory input from the periphery [10-12]. Increased activity and sensory input from the hand results in expansion of the cortical hand representation [13-15], while decreased sensory input, for instance by anaesthesia, amputation or nerve injury, results in shrinkage of the cortical hand representation [16-21]. Due to the constant ongoing "cortical competition" between body parts the adjacent cortical areas expand and take over the silent area, deprived of sensory input.
Read more
The investigators have recently described striking examples of such rapid cortical re-organisations induced by selective cutaneous anaesthesia of the forearm: application of EMLA cream to the volar aspect of the forearm results in improved sensory functions of the hand [18] linked to expansion of the hand representational area in sensory cortex . In analogy, EMLA application to the lower leg in healthy controls results in improved sensory functions in the sole of the foot linked to expansion of the foot representational area in sensory cortex.
To test the hypothesis that EMLA application to the lower leg of diabetic patients will result in improved sensory functions in the sole of the foot as well as expansion of the foot representation in sensory cortex. The investigators hypothesize that repeated applications of EMLA will result in a long lasting sensibility improvement.
- Conditions
- Diabetes Mellitus
- Being tested
- EMLA cream
- Keywords
- Diabetes mellitus, neuropathy, foot, sensibility, brain plasticity
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA creamDrug
The study subjects are treated either by 50 g of a local anesthetic agent containing 2.5% Lidocaine and 2.5% Prilocaine (EMLA®, AstraZeneca - Södertälje, Sweden) or a placebo cream, applied to the lower leg. The cream is applied under occlusive bandage (plastic foam and a tube) for 1.5 hours circumferential to the lower leg 10-12 cm distally of the tibial tuberosity and the malleolus at ankle level. Administration of the treatment cream as well as removal after 1,5 hour and at sensory assessment after 1.5 hour and 24 hours, and interviewing the patient about subjective experience from the treatment are performed by an independent research nurse, not involved in the sensory assessment.
EMLA creamDrug
50g applied according to description of intervention
| Study group | Role | What they receive |
|---|---|---|
| EMLA cream | Experimental | Not described Receives: Drug: EMLA cream |
| Placebo cream | Placebo comparator | A placebo cream identical in appearance and consistency to the experimental cream Receives: Drug: EMLA cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments)
Measured: Screening, before application, 90 min after application, 24 hours after application
Secondary outcomes (2)
MRI
Measured: MRI-examination, before application, 90 min after application, 24 hours after application
fMRI
Measured: fMRI-examination, before application, 90 min after application, 24 hours after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Lundborg, Lund University Hospital
- Investigators
- Göran Lundborg, Professor, Principal investigator, Dpt of Hand Surgery, Malmö University Hospital, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959595
- Sponsor's protocol ID
- 2008-001834-29
- Other IDs
- 2008
- Status last verified
- Dec 2013
- First submitted
- 12 Aug 2009
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lundborg GN, Bjorkman AC, Rosen BN, Nilsson JA, Dahlin LB. Cutaneous anaesthesia of the lower leg can improve sensibility in the diabetic foot. A double-blind, randomized clinical trial. Diabet Med. 2010 Jul;27(7):823-9. doi: 10.1111/j.1464-5491.2010.03014.x.
PubMed 20636964
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Sensibility in the Sole of the Foot in Diabetic Patients, Induced by EMLA-application to the Lower Leg - a Double Blind Study
- ClinicalTrials.gov ID
- NCT00959595
- Acronym / sponsor ID
- 2008-001834-29
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, neuropathy, foot, sensibility, brain plasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Aug 2009 (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.
Sensory input from the foot as well as all other body parts results in activation of sensory cortex.
It is well known that the cortical body map is experienced-dependant and can rapidly change in response to changes in activity and sensory input from the periphery [10-12]. Increased activity and sensory input from the hand results in expansion of the cortical hand representation [13-15], while decreased sensory input, for instance by anaesthesia, amputation or nerve injury, results in shrinkage of the cortical hand representation [16-21]. Due to the constant ongoing "cortical competition" between body parts the adjacent cortical areas expand and take over the silent area, deprived of sensory input.
The investigators have recently described striking examples of such rapid cortical re-organisations induced by selective cutaneous anaesthesia of the forearm: application of EMLA cream to the volar aspect of the forearm results in improved sensory functions of the hand [18] linked to expansion of the hand representational area in sensory cortex . In analogy, EMLA application to the lower leg in healthy controls results in improved sensory functions in the sole of the foot linked to expansion of the foot representational area in sensory cortex.
To test the hypothesis that EMLA application to the lower leg of diabetic patients will result in improved sensory functions in the sole of the foot as well as expansion of the foot representation in sensory cortex. The investigators hypothesize that repeated applications of EMLA will result in a long lasting sensibility improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMLA cream | Experimental | Drug: EMLA cream |
| Placebo cream | Placebo comparator | Drug: EMLA creamA placebo cream identical in appearance and consistency to the experimental cream |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18-75 years) suffering from diabetes with subjective sensory impairment in the sole of the foot.
Key exclusion criteria (2 listed)
- Patients with painful neuropathy or established ulcer formation in toes or sole of the foot, known hypersensitivity to local anaesthetics, major vascular reconstructions, communication problems due to severe language problems.
- Patients with pacemakers or magnetic implants or suffering from claustrophobia will not be subjected to fMRI-investigation.
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 |
|---|---|---|
| EMLA creamThe study subjects are treated either by 50 g of a local anesthetic agent containing 2.5% Lidocaine and 2.5% Prilocaine (EMLA®, AstraZeneca - Södertälje, Sweden) or a placebo cream, applied to the lower leg. The cream is applied under occlusive bandage (plastic foam and a tube) for 1.5 hours circumferential to the lower leg 10-12 cm distally of the tibial tuberosity and the malleolus at ankle level. Administration of the treatment cream as well as removal after 1,5 hour and at sensory assessment after 1.5 hour and 24 hours, and interviewing the patient about subjective experience from the treatment are performed by an independent research nurse, not involved in the sensory assessment. | Drug | EMLA cream |
| EMLA cream50g applied according to description of intervention | Drug | EMLA cream, Placebo cream |
Primary outcome
Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments)
Time frame: Screening, before application, 90 min after application, 24 hours after application
2 secondary outcomes
MRI
Time frame: MRI-examination, before application, 90 min after application, 24 hours after application
fMRI
Time frame: fMRI-examination, before application, 90 min after application, 24 hours after application
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 16 Dec 2013.
- Results publication: PubMed 20636964Lundborg GN, Bjorkman AC, Rosen BN, Nilsson JA, Dahlin LB. Cutaneous anaesthesia of the lower leg can improve sensibility in the diabetic foot. A double-blind, randomized clinical trial. Diabet Med. 2010 Jul;27(7):823-9. doi: 10.1111/j.1464-5491.2010.03014.x.
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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.
Göran Lundborg, Professor principal investigator
Dpt of Hand Surgery, Malmö University Hospital, Lund University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EMLA cream in people with Diabetes Mellitus, run by Lund University Hospital at 1 site in Sweden.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 16 Dec 2013. 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 Sweden. 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. 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 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 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.
What does the primary outcome measure?
Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments) (time frame: Screening, before application, 90 min after application, 24 hours after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959595, which also lists 1 linked publication.
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 16 Dec 2013.