NCT02577120

Wound Healing Endpoint and Recurrence

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sashwati Roy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a continuation of a previously approved protocol conducted at Ohio State University and Indiana University. The first two aims of the original protocol have been completed, and this protocol will finish enrollment for the third aim, comparing Hi TEWL and Low TEWL measurements, and whether a HiTEWLmeasurement indicates a seemingly healed wound is more likely to recur/reopen toa new wound. Of the 105 desired subjects, 62 subjects have already been recruited and completed their study participation at the previous university. 43 additional subjects will be recruited to complete the enrollment goal here at the University of Pittsburgh.

Detailed description

In the United States, chronic wounds represent a major public health burden. Estimates put the number of chronic wounds cases at over 6.5 million with a cost burden of over $50 billion14. According to the current standard of care (SoC), wound closure is assessed visually. The FDA defines complete wound closure of chronic non-healing wounds as "skin closure (as assessed visually) without drainage or dressing requirements identified at two consecutive study visits that are 2 weeks apart" and requires therapeutic trials for chronic wounds to be designed such that the enrolled patients will be evaluated for at least 3 months following completeclosure19. The expectation is that successful intervention should keep the wound closed for at least 90 days. This study contends that visual inspection of wounds is insufficient to certify closure - a critical endpoint that drives treatment decisions. Considering that almost two-thirds of all chronic wounds are estimated to be biofilminfected6, and the observation that biofilm-infected wounds may be visually closed but functionally (barrier function) open, the significance of the proposed hypothesis is substantial. The proposed study has the clear potential to lay a strong rationale that would potentially change the wound care paradigm by requiring that measurement of skin barrier function be the new endpoint to define wound closure. Reported recurrence rates for most chronic ulcer types remain extremely high, ranging from 40-79%4,5, 24%-57% for venous ulcers, and upward of 60% for diabetic ulcers supporting the importance of preventive efforts1,2. In that context it is of extraordinary significance to ask whether "defective closure" (visually closed with TEWL (Trans-Epidermal Water Loss) \>3x the value of intact skin; high TEWL) predicts poor post-closure outcome e.g. recurrence. These questions may only be meaningfully asked in a patient-based pilot and that is exactly the intent of Aim 2. Findings of the proposed pilot will inform a larger future trial.

Conditions

• Chronic Wound
• Burn Wound
• Diabetic Foot Ulcers
• Pressure Ulcers
• Venous Leg Ulcers
• Chronic
• Wound

Interventions

Type	Name	Description
DEVICE	Epiceram Skin Barrier Function	Epiceram is a non-sterile, viscous, lipid-rich emulsion
BIOLOGICAL	Vaseline Petroleum Jelly	A skin protectant used for temporarily protecting minor cuts, scraps, burns, and helps to protect and help relieve chapped or cracked skin and lips.

Timeline

• Start date: 2019-01-08
• Primary completion: 2029-02-01
• Completion: 2034-02-01
• First posted: 2015-10-16
• Last updated: 2025-09-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study