Wound Healing Endpoint and Recurrence

Diabetic Foot Ulcers Clinical Trial

Official title: Wound Healing Endpoint and Recurrence

Status Suspended

Clinical Trial Summary

This prospective pilot study is to enroll patients with clinically-defined infected wounds. Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound patients will be recruited for this study in Phase A. Based on the expectation that 89% of these wounds will heal within 16 weeks of enrollment, 234 of these patients will continue with the study for Phase B.

Clinical Trial Description

This prospective pilot study is to enroll patients with clinically-defined infected wounds. Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and will then begin Phase B. Wounds will be subjected to Standard of Care (SoC) followed by all Comprehensive Wound Center (CWC) wound physicians in the first 16 weeks. Trans - Epidermal Water Loss (TEWL) will be measured with a handheld, non-invasive device, the VapoMeter® Closed-Chambered device or using DermaLab TEWL probe. Both of these devices are used to read the device. They will be placed on the subjects skin and will read the TEWL measurement. When the device is placed on the skin, the measurement takes between 7-20 seconds with the standard adapter.

Study visit 1 will include informed consent being signed, baseline information collected, 2 biopsies will be collected unless the wound is not appropriate for biopsy or the patient chooses not to receive a biopsy then a swab for culture will be collected, wound image using a digital camera and Wound Vision Scout (a non-invasive, infrared imaging camera), and a quality of life survey will be completed by the subject. The patients medical chart will be followed for 16 weeks following visit 1. At 16 weeks (+/- 2 weeks) or within 10 days of wound closure whichever comes first, all subjects will return for study visit 2. If the target wound(s) is not yet healed at this visit, this visit will be part of their Standard of Care visit per the CWC. The patient's study participation will end at this visit but wound data will be collected, digital imaging of wound(s) and quality of life survey will be completed by the subject. If the target wound is determined by visual inspection to be healed at or prior to this visit, this will be a research only visit; the patient will continue to Phase B, a continuation of study visit 2. Various information will be collected on the data collection sheet, digital imaging and TEWL measurements will be recorded. The TEWL device will be placed on the skin. There will be 5 measurements obtained over the closed wound site. A reference (control) TEWL measurement will be taken from intact skin at an anatomically matched site on the patient.

A high TEWL/ defective closure is defined as a TEWL value that equals 2 times the value of the patient's control measurement. Patients who meet this criterion will be randomized to one of four groups: EpiCeram treatment, Ceramiseal treatment, Vaseline treatment or no treatment. Patients randomized to a treatment group will be supplied with study product and will be instructed to apply twice daily to the closed wound site for the remaining weeks of the study. All High TEWL patients will be asked to return for Study Visits 3-6. Distribution of study product as applicable. For this study, a low TEWL/ adequate closure is defined as a value less than 2 times the value of the patient's control measurement. Patients who meet this criterion will not be randomized into a treatment group, but will continue to receive standard of care per their physician and will be asked to return for study visits 3, 4, and

6. During these last visits the following activities will occur: TEWL measurements, digital imaging, sequential tape stripping to measure ceramide levels in the skin (up to 20 tape strips obtained). TEWL measurements will be obtained prior to tape stripping. The tape strips be completed after the TEWL measurements are obtained, wound site evaluation, various labs, medications review, distribution of study product (High TEWL only) and review of compliance and a quality of life survey is completed by the subject (visit 6 only).

There may be some discomfort with the tissue biopsy procedure depending on the amount of sensation the subject has at the site of the wound and will be numbed by applying local anesthesia as appropriate to area being biopsied. The amount of pain that occurs with wound biopsies will vary from person to person, but all efforts will be made to minimize pain and is within the boundaries of the existing wound to avoid giving the patient a separate new wound. Bleeding is a possible complication, but the risk is low for the small biopsies and is reduced by using local anesthetics with epinephrine, and silver nitrate sticks are available in each patient room to cauterize biopsy sites as needed. Infection is also a potential risk; however, wound tissue biopsies are routinely performed as the standard of care in the CWC to diagnose wound infection. The biopsy site will be appropriately monitored for infection by the physician managing the wound during routine wound clinic visits.

Possible risks for the use of the ceramide emulsion EpiCeram® are a temporary tingling sensation (10-15 minutes) and an extremely low risk of an allergic reaction. If this occurs the application of the cream will be stopped immediately. Possible risks for the use of Vaseline Petroleum and Ceramiseal™ are very low should be stopped if an allergic reaction occurs.There can be some minor redness and discomfort at the site of the tape stripping. The skin remains intact, i.e. the epidermis is not breached after the tape stripping procedure making this less than minimal risk. TEWL measurements are noninvasive and propose less than minimal risk. ;

Related Conditions & MeSH terms

• Burn Wound
• Chronic
• Chronic Wound
• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Leg Ulcer
• Pressure Ulcer
• Pressure Ulcers
• Recurrence
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers
• Wound
• Wounds and Injuries

• NCT number: NCT02577120
• Study type: Interventional
• Source: Indiana University
• Status: Suspended
• Phase: Phase 4
• Start date: January 8, 2019
• Completion date: February 2025