Health TrialsbyHealthPanel

4-Aminopyridine to Treat Skin Burns

ConditionsBurnsSecond Degree BurnWounds and Injuries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Elfar

About this trial

Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Injured (burned) adults with a maximum severity of second-degree burns.

Burns involving at least 6cm2 of skin area

Acute burns within 7 days of injury

Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination.

Disqualifiers

History of multiple sclerosis, stroke or any other diagnosed neurological disorder

History of hypersensitivity to AMPYRA® or 4-aminopyridine

Current use of aminopyridine medications, including other compounded 4-AP

Suspected renal impairment based on the Choyke questionnaire.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug: 4-Aminopyridine

    Drug

    Active study drug

  • Placebo

    Other intervention

    Placebo comparator

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Group A: 4-aminopyridineActive comparator 1 intervention
Group B: Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Healing rate

Each subject will undergo detailed fiducial-marking augmented macroscopic imaging to determine baseline burn area measurement. These measurements will be repeated at each follow up study visit to assess healing rate.

Time frame
12 months

Secondary outcomes

1

Skin-graft rate

Skin-graft rate (failure of healing)

Time frame
12 months
2

Scar formation

Scar formation will be measured by the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS is rated on a 10-point score with total scores ranging from 6 to 60 with higher scores indicating increase severity of symptoms. These measurements will be repeated at each follow up study visit.

Time frame
12 months
3

Scar sensitivity

Scar sensitivity will be measured by the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS is rated on a 10-point score with total scores ranging from 6 to 60 with higher scores indicating increase severity of symptoms. These measurements will be repeated at each follow up study visit to assess healing rate.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John Elfar

Lead sponsor

University of Arizona

Sponsor institution

Source ClinicalTrials.gov
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