Summary of Studies

What is Accelerex®?

Accelerex is a brand-new impregnated wound dressing and cream that helps to normalize the micro-environment of your wound.

Accelerex typically normalizes the micro-environment of a chronic wound in two weeks. Once the wound bed’s microenvironment is normalized, the body’s normal, natural healing process is able to regenerate and rebuild tissues in the wound.

A Randomized Double-Blind Study to Evaluate the Effects of MMP Down Regulators, on Two Different Topical Preparations, on the Healing of Partial Thickness Wounds in Healthy Human Volunteers.

A computer generated randomized table was used to assign one of four treatment regimens. These included a placebo, non-treated dressing, active ingredient in emulsion at 1.17% and active ingredient in emulsion at 4.88%.

Wounds were clinically evaluated for epithelialization, granulation, exudate production, erythema, edema induration, reinjury, and pain level (upon application of the test agent and throughout the course of treatment).

Study shows higher concentration of the active ingredient to be the most effective in healing wounds in healthy human subjects in all clinical categories evaluated.

The Art of Balancing the Wound Micro-Environment: How to Treat Chronic Wounds in Another Way

Hoekstra

This study is a semi-comprehensive compilation of the wound healing process, and treatments for chronic wounds.

This document includes a look into the healing process, the characteristics of non-responding wounds or various causes, and protocols for treating these wounds.

The document discusses the importance of MMP’s in the healing process and their role in contributing to non-responsive wounds if they are not down regulated as needed.

An Observational Study of the Use of a Polyhydrated Ionogen Impregnated Dressing (Accelerex®) in the Treatment of Wounds

Study Performed by: TissueViability Consultancy Services, Ltd.

This clinical study was based on a series of case studies and is not strictly based on research principles. The overall aim was to demonstrate how Accelerex® can be used in general, hard to heal wounds, in order to rebalance MMP’s through normalization of the wound micro-environment. Healing in “real life” wounds cannot be shown through randomized Controlled Trials, as the inclusion/exclusion criteria are so strict that it excludes the wound types that are currently causing difficulties with healing in the community. In these case studies, there was an overall healing rate of 48% of those wounds treated with Accelerex® and a predicted potential for a 72% healing rate.

The cost effectiveness of Accelerex® is without doubt. A 72% healing rate means that in 72% of the cases, cost savings are 100%. Accelerex® has been well accepted by both the patients and the Health Care Professionals and the healing rates are shown to be excellent in all these extremely difficult to heal wounds.

3M studies

Accelerex® has been well accepted by both the patients and the Health Care Professionals and the healing rates are shown to be excellent in all these extremely difficult to heal wounds.

Overview Pre-Market Clinical Evaluation and Post Market Clinical Follow Up of Tegaderm™ Matrix PHI

Study Performed by: Van Loon Dermagenics, Inc.

This document provides an overall summary of the pre-market Clinical Evaluation data and Post Market Clinical Follow Up (PMCF) data relevant for Tegaderm™ Matrix PHI.

The PMCF studies aimed to evaluate the clinical safety and performance of the Tegaderm™ Matrix PHI.

To evaluate the Post Market Clinical safety and performance, input was pro-actively collected, including complaints from the field. During the PMCF evaluation periods the performance of wounds in a total of more than 200 wounds, including leg ulcers, Decubitus, diabetic ulcers, and post-surgical wounds, have been reported.

Between 2003-2006, 78% of the wounds did show complete healing and/or improvement. The poor healing tendency of the remaining 22% was mostly related to generally known indications. Only 4% of the total wounds described a stinging/burning sensation, while patients with leg ulcers reported a pain reduction.

Overall, the clinical performance of the Tegaderm™ Matrix PHI treatment has overall been recognized as very effective.

MMP-2 Assessment as an Indicator of Wound Healing: A Feasibility Study

Karim

The objective of this study was to evaluate the feasibility of assessment of fibroblast matrix metalloproteinase-2 (MMP-2) expression as an indicator of wound healing in wounds that change from chronically inert to actively healing.

This was a Phase II feasibility study of 4 patients with nonhealing wounds. Wounds were treated with a dressing impregnated with oak bark extract (Accelerex®) and evaluated weekly. Biopsies were performed every 2 weeks until wound healing.

The therapy-induced wound healing and immune histochemical measurements of MMP-2 expression paralleled the clinical characteristics of wound healing.

In conclusion, MMP-2 expression offers a reliable indicator for clinical wound healing induced by Accelerex® treatment.

The Use of PHI Dressings on Hard to Heal Wounds

Hendrix

Visual documentation of clinical efficacy of MMP down-regulators on six different Stage III and Stage IV foot wounds. Five of the six wounds were healed in approximately three months, with only one wound requiring six months.