SerenaGroup Medical Research has conducted more than 50 clinical trials, ranging from novel antibiotics to bioengineered skin, growth factors, and platelet gels.

SerenaGroup is recognized internationally as being in the forefront of wound healing research. Our large patient volume affords us the ability to conduct clinical trials for all of the major pharmaceutical and device companies.

We conduct research at all of our wound care clinics, which has resulted in more than 75 published papers and over 175 presentations worldwide. Our clinical trials make novel treatments available to a patient population with diabetes and venous insufficiency while providing a modest revenue stream for our hospitals.

For additional information regarding research and clinical trials, please contact us at:

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Summer 2011

Download our current Newsletter
September 2010

Download our previous Newsletter
November 2009

 

Current Clinical Trials

Current Trials – April 2011

Analysis of Connexin Distribution in Various Skin Wounds (CoDa Therapeutics, Inc.)
Protocol #: NEX-ULC-006
Goal: To measure the levels of Connexin molecules along with other proteins and molecules in chronic wounds and normal skin to evaluate their effect on wound healing.
Locations: Erie, Armstrong

A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft® in Subjects with Venous Leg Ulcers (Advanced BioHealing)
Protocol #: ABH-DERMAGRAFT-001-08
Goal: To assess the safety and effectiveness of Dermagraft®, together with four layer compression bandaging therapy, in assisting the healing of venous leg ulcers compared with conventional treatment of four layer compression bandaging therapy alone.
Locations: Erie, Armstrong

A Prospective, Multi-Center, Longitudinal, Cohort Study of Dermagraft® in Subjects with Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial (Advanced Biohealing)
Protocol #: ABH-DERMAGRAFT-001-09
Goal: To assess the long term safety and effectiveness of Dermagraft® together with multi-layer compression bandaging therapy in assisting the healing of venous leg ulcers compared with the conventional treatment of multi-layer compression bandaging therapy alone.
Locations: Erie, Armstrong

Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (HealOr, Ltd.)
Protocol #: HO-09-01
Goal: To determine the safety and efficacy of HO/03/03 in addition to standard of care versus placebo in addition to standard of care in the healing of diabetic foot ulcers.
Location: Armstrong

A Multi-center, Randomized, Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers (Integra LifeSciences Corporation)
Protocol #: IDRT/DFU US-2009-3
Goal: To assess the safety and efficacy Integra® Dermal Regeneration Template compared to a moist wound dressing (standard of care) in healing diabetic foot ulcers.
Location: Erie

A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients with Epidermolysis Bullosa (RegeneRx Biopharmaceuticals, Inc.)
Protocol #: SSEB
Goal: To determine the safety and efficacy of Thymosin Beta 4 gel in comparison to a placebo gel in improving the healing of recurrent skin lesions in subjects with epidermolysis bullosa.
Location: Erie

Validation of a Point of Care Rapid Diagnostic Swab to Determine Protease Levels in Chronic Wounds (Systagenix)
Protocol #: SOFIA-01
Goal: To determine the accuracy of an investigational tool that tests for harmful enzymes called proteases.
Location: Erie

A Long-Term Follow-Up Study of Subjects Who Were Previously Enrolled in Tissue Repair Company- Sponsored Clinical Trials Using GAM501 (Tissue Repair Company)
Protocol #: SWHI-02
Goal: To evaluate the long-term health status of subjects who participated in the GAM501 study.
Location: Warren

Upcoming Trial (May 2011)

A Randomized, Parallel Group, Dose-Ranging, Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nexagon in the Treatment of Subjects with a Venous Leg Ulcer (CoDa Therapeutics, Inc.)
Protocol #: NEX-ULC-007
Goal: To assess the safety and efficacy of Nexagon combined with multi-layer compression bandaging therapy in healing venous leg ulcers.
Locations: Erie, Armstrong, Tulsa

Closed Trials (closed this year to date)

Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial (Spiracur, Inc.)
Protocol #: 041609
Goal: To evaluate a negative pressure wound therapy device called the SNAP Wound Care System for the treatment of lower extremity diabetic and venous ulcer wounds.
Locations: Erie, Armstrong, Warren

A Randomized Double-Blind Placebo-Controlled Parallel Group Study Of The Efficacy And Safety Of 4 Administrations Of XRP0038/NV1FGF 4MG At 2-Week Intervals On Amputation Or Any Death In Critical Limb Ischemia Patients With Skin Lesions (sanofi-aventis)
Protocol #: EFC6145
Goal: To demonstrate the superiority of 4 administrations of XRP0038/NV1FGF 4 mg at 2 week intervals over placebo in the prevention of major amputation above the ankle of treated leg or of death from any cause, whichever comes first, in critical limb ischemia patients with skin lesions.
Location: Warren

The Mechanism of Action of Unite™ Biomatrix in Diabetic Foot Ulcer (Synovis Orthopedic and Woundcare)
Protocol #: U0801
Goal: To assess the mechanism of action of the Unite™ Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.
Location: Tulsa