The RESPOND Registry

Summary

The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.

Conditions

• Partial Thickness Wound
• Pressure Ulcer
• Venous Ulcer
• Diabetic Ulcer
• Surgical Wounds
• Trauma Wounds
• Draining Wounds
• Chronic Vascular Ulcer

Interventions

DEVICE

PuraPly™ Antimicrobial Wound Matrix

PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.

Sponsors & Collaborators

• Continuum Clinical Inc.

  collaborator UNKNOWN

• Organogenesis

  lead INDUSTRY

Principal Investigators

• Adam J Teichman, DPM · PA Foot and Ankle Association

• Shaun Carpenter, M.D. · Wound Care Associates, LLC.

• Daniel L Kapp, M.D. · Jupiter Medical Center

• Kerry Thibodeaux, M.D. · Opelousas General Hospital Wound Center

• George Koullias, M.D. · Southampton Hospital

• Raymond Abdo, DPM · Saint Louis Foot and Ankle

• Barry Wisler, DPM · Robert Wood Johnson Hamilton

• Carlos Trabanco, MD · West Gables Rehabilitation Hospital

• Ifat Kamin, MD · Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute

• Amanda Estapa, NP · Institute for Advanced Wound Healing; Northshore Specialty Hospital

• Michael Menack, MD · CentraState Medical Center

• Ritu Gothwal, MD · Advanced Wound Care Center at Yavapai Regional Medical Center

• Mark Iafrati, MD · Tufts Medical Center

• Paula Pons, MD · Saint Joseph's Center for Wound Care and Hyperbaric Medicine

• Taysha Howell, MD · Oklahoma Wound Center

• Allan Grossman, DPM · Harrisburg Foot and Ankle Center, Inc.

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-21

Primary Completion

2018-07-15

Completion

2019-01-26

FDA Device

Yes

Countries

• United States

Study Locations