Clinical trial NCT02445235: Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy
Official title: Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain
Fungal Infection
Keywords: pain
wound care
fungal infections
scars
chronic pain
outcomes
PRO
Lead sponsor: Bracane Company
Sponsor class: INDUSTRY
Collaborators: name: IFG Medical
First posted: 2015-05-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Must be receiving therapy for pain, wound care or scar therapy

Brief summary: This observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. The patients will complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.

Detailed description: This observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. The patients will complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.

Patients are enrolled for 18 months. The investigator will complete a global patient assessment monthly of the patient's condition.

Eligibility criteria: Inclusion Criteria:

1. An 18 to 85 years old (inclusive) female or male patient
2. Prescribed compound for the treatment of pain, wound healing or surface skin scar by their Principal Investigator
3. Any systemic disease (cardiac, renal, or hepatic) must be well controlled.
4. Has no skin lesions at the site of application of study medication except for wound under treatment
5. Able to provide informed consent

Exclusion Criteria:

1. Pregnant or lactating females or women at the child bearing potential not using effective contraception.
2. Use of other topical or transdermal medication. Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.
3. Hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study.
4. Prior reconstruction skin surgery or skin grafts in the area of cream application preventing absorption of cream except for the treatment of surface skin scar
5. Chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer, or gouty arthritis.

Primary outcomes:
measure: Change in Baseline PRO and Health Status Perception
timeFrame: Up to eighteen (18) months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: BG Research
state: Kentucky
city: Sevierville
country: United States
facility: Sevierville Foot and Ankle Clinic
state: Tennessee
city: Fort Worth
country: United States
facility: Associates of Internal Medicine
state: Texas
Study officials:
affiliation: Bracane Company
name: Pamela Nelson, RN, MS
role: STUDY_DIRECTOR
affiliation: IFG Medical
name: Matt Fruge, BS
role: STUDY_CHAIR
References: