The RESPOND Registry (RESPOND)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03286452 |
Recruitment Status :
Completed
First Posted : September 18, 2017
Last Update Posted : February 27, 2019
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Condition or disease | Intervention/treatment |
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Partial Thickness Wound Pressure Ulcer Venous Ulcer Diabetic Ulcer Surgical Wounds Trauma Wounds Draining Wounds Chronic Vascular Ulcer | Device: PuraPly™ Antimicrobial Wound Matrix |
The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings as it leads to an improvement in wound bed condition (i.e increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of exudate).
The RESPOND Registry is a prospective, non-interventional research initiative to collect information on patients who are eligible to receive PuraPly™ AM, and no interventional procedures will be mandated by this protocol.
Enrolled and eligible patients will receive standard wound care clinical assessments and any additional care as determined by the treating wound care clinician. Although multiple wounds may be treated simultaneously, one wound will be identified as the target wound, and characteristics regarding this wound will be consistently documented.
The case series is being undertaken to better understand PuraPly™ AM utilization and subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy on healing. Patient's participation may involve follow-up for up to 24 weeks following application of PuraPly™ AM.
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 310 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 24 Weeks |
Official Title: | Real-World Effectiveness Study of PuraPly™ AM on Wounds |
Actual Study Start Date : | February 21, 2017 |
Actual Primary Completion Date : | July 15, 2018 |
Actual Study Completion Date : | January 26, 2019 |

- 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.Other Names:
- PuraPly™ Antimicrobial
- PuraPly™ AM
- Reduction in size of wound area [ Time Frame: Up to 24 weeks ]As measured from change in size from baseline
- Time to complete wound closure [ Time Frame: Up to 24 weeks ]As measured by time to complete wound closure from baseline
- Improvement in wound bed condition [ Time Frame: Up to 24 weeks ]As measured from change in status from baseline
- Improvement in patient reported pain [ Time Frame: Up to 24 weeks ]As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
- Improvement in patient reported quality of life [ Time Frame: Up to 24 weeks ]As measured by change in status from baseline as assessed by the SF-12 QoL.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient is at least 18 years of age.
- Patient, or their legally authorized representative (LAR), has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
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Patient has a wound appropriate for receiving PuraPly™ AM, including:
- Partial or full-thickness wound
- Pressure ulcer
- Venous ulcer
- Diabetic ulcer
- Chronic vascular ulcer
- Tunneled/undermined wound
- Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery, podiatric surgery wound, wound dehiscence)
- Trauma wound (abrasions, lacerations, second degree burns, and skin tears)
- Draining wound
Exclusion Criteria:
- Patient has a known sensitivity to porcine materials.
- Patient has a third-degree burn.
- Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB).
- Patient's target wound was previously treated with PuraPly™ AM.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286452
United States, Arizona | |
Advanced Wound Care Center at Yavapai Regional Medical Center | |
Prescott Valley, Arizona, United States, 86314 | |
United States, Florida | |
Jupiter Medical Center | |
Jupiter, Florida, United States, 33458 | |
West Gables Rehab Hospital | |
Miami, Florida, United States, 33155 | |
United States, Louisiana | |
Institute for Advanced Wound Healing; Northshore Specialty Hospital | |
Covington, Louisiana, United States, 70433 | |
Wound Care Associates, LLC. | |
Hammond, Louisiana, United States, 70403 | |
Opelousas General Hospital Wound Center | |
Opelousas, Louisiana, United States, 70570 | |
United States, Missouri | |
Saint Louis Foot and Ankle | |
Saint Louis, Missouri, United States, 63128 | |
United States, New Jersey | |
CentraState Medical Center | |
Freehold, New Jersey, United States, 07728 | |
Robert Wood Johnson Hamilton | |
Hamilton, New Jersey, United States, 08690 | |
United States, New York | |
Southampton Hospital | |
Southampton, New York, United States, 11968 | |
United States, North Carolina | |
Wayne Memorial Hospital | |
Goldsboro, North Carolina, United States, 27534 | |
United States, Pennsylvania | |
Sacred Heart Hospital | |
Allentown, Pennsylvania, United States, 18104 | |
Harrisburg Foot and Ankle Center, Inc. | |
Harrisburg, Pennsylvania, United States, 17112 | |
United States, South Carolina | |
Greensville Health System | |
Greenville, South Carolina, United States, 29605 | |
United States, Wisconsin | |
Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute | |
Madison, Wisconsin, United States, 53713 |
Principal Investigator: | Adam J Teichman, DPM | PA Foot and Ankle Association | |
Principal Investigator: | Shaun Carpenter, M.D. | Wound Care Associates, LLC. | |
Principal Investigator: | Daniel L Kapp, M.D. | Jupiter Medical Center | |
Principal Investigator: | Kerry Thibodeaux, M.D. | Opelousas General Hospital Wound Center | |
Principal Investigator: | George Koullias, M.D. | Southampton Hospital | |
Principal Investigator: | Raymond Abdo, DPM | Saint Louis Foot and Ankle | |
Principal Investigator: | Barry Wisler, DPM | Robert Wood Johnson Hamilton | |
Principal Investigator: | Carlos Trabanco, MD | West Gables Rehabilitation Hospital | |
Principal Investigator: | Ifat Kamin, MD | Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute | |
Principal Investigator: | Amanda Estapa, NP | Institute for Advanced Wound Healing; Northshore Specialty Hospital | |
Principal Investigator: | Michael Menack, MD | CentraState Medical Center | |
Principal Investigator: | Ritu Gothwal, MD | Advanced Wound Care Center at Yavapai Regional Medical Center | |
Principal Investigator: | Mark Iafrati, MD | Tufts Medical Center | |
Principal Investigator: | Paula Pons, MD | Saint Joseph's Center for Wound Care and Hyperbaric Medicine | |
Principal Investigator: | Taysha Howell, MD | Oklahoma Wound Center | |
Principal Investigator: | Allan Grossman, DPM | Harrisburg Foot and Ankle Center, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Organogenesis |
ClinicalTrials.gov Identifier: | NCT03286452 |
Other Study ID Numbers: |
16-REG-002-PPAM |
First Posted: | September 18, 2017 Key Record Dates |
Last Update Posted: | February 27, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Antimicrobial Collagen Bioburden Biofilm |
PHMB Chronic wounds Acute wounds |
Varicose Ulcer Pressure Ulcer Ulcer Wounds and Injuries Surgical Wound Pathologic Processes Skin Ulcer |
Skin Diseases Varicose Veins Vascular Diseases Cardiovascular Diseases Leg Ulcer Anti-Infective Agents Anti-Bacterial Agents |