A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers

Study Purpose

This real-world, observational registry captures structured data on chronic wounds and ulcers from 1,482 practitioners across all 50 U.S. states and Puerto Rico. Data are collected at the point of care through electronic health records (EHRs) or electronic data capture (EDC) systems and transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry supports quality improvement and comparative effectiveness research by providing insight into patient demographics, treatment patterns, and outcomes across a wide range of wound types and interventions.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Presence of one or more chronic wounds or ulcers of any etiology treated at a participating site using the wound-specific structured EHR or EDC system. Age: Any (including infants and adults 90 years or older, though reported in aggregate due to HIPAA). All patients and all wounds on all patients are enrolled so that there is no patient or wound selection bias.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02280733
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

U.S. Wound Registry
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Caroline E Fife, MD
Principal Investigator Affiliation Intellicure LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis, Skin Ulcer, Leg Ulcer, Wounds and Injuries, Pyoderma, Peripheral Arterial Disease, Lymphedema, Venous Insufficiency, Diabetes Complications, Amputation Stump, Surgical Complication, Venous Leg Ulcers (VLUs), Diabetic Ulcers on Both Feet, Calciphylaxis, Sickle Cell Ulcer, Traumatic Wounds and Injuries, Pressure Ulcer (PU), Pressure Injury, Arterial Ulcers, Radionecrosis
Study Website: View Trial Website
Additional Details

This is a longitudinal, non-interventional registry study of chronic wounds and ulcers managed at hospital-based outpatient wound centers. Data collection began in 2005 and continues prospectively. Participating centers use structured clinical documentation tools within certified EHR or EDC systems to capture real-time, research-ready data during routine clinical care. Data from all patients are securely transmitted to the U.S. Wound Registry (USWR), which serves as a CMS-designated Qualified Clinical Data Registry (QCDR). As of the date of this update, the registry includes:

  • - 226,913 patients.
  • - 752,727 discrete wounds.
  • - Data from 1,482 clinicians.
  • - Participation from all 50 U.
S. states and Puerto Rico.The registry includes all types of chronic wounds and ulcers, including but not limited to:
  • - Diabetic foot ulcers (DFUs) - Non-foot diabetic ulcers.
  • - Venous leg ulcers (VLUs) - Arterial ulcers.
  • - Pressure ulcers/injuries (PU/PI) on the torso and lower extremities.
  • - Surgical wounds.
  • - Traumatic wounds.
  • - Vasculitic, sickle cell, inflammatory (e.g., pyoderma gangrenosum), and scleroderma-related ulcers.
Interventions tracked include a wide range of advanced wound care therapies, captured both by category and by brand where applicable. These include:
  • - Advanced dressings (including collagen and antimicrobial dressings by brand) - Compression bandaging (by brand) - Off-loading devices (by brand) - Cellular and/or tissue-based therapies (skin substitutes, by brand) - Negative pressure wound therapy (by brand) - MIST therapy (low-frequency ultrasound) - Topical oxygen therapy (by brand) - Non-contact fluorescent imaging.
  • - Topical growth factors such as becaplermin.
  • - Enzymatic debridement agents including collagenase.
  • - Various topical antibiotics and other treatments.
Wounds are risk stratified using the Wound Healing Index to support case-mix adjusted outcome analysis. Outcomes may occur at any time following enrollment and are captured longitudinally. Patients may be followed for over five years. The following outcomes are recorded:
  • - Healed (fully epithelialized without drainage) - Not healed (persisting open ulcer) - Major amputation (above the ankle or wrist) - Minor amputation (below the ankle or wrist) - Lost to follow-up or transferred care.
  • - Patient died.
Quality of care is assessed using wound-specific quality measures developed through the QCDR program. Registry participation supports regulatory reporting, including the registry option for Stage 2 of Meaningful Use and MIPS QCDR quality reporting. All registry data are managed by the U.S. Wound Registry (USWR), headquartered in The Woodlands, Texas. The U.S. Wound Registry (USWR) is recognized by the Centers for Medicare & Medicaid Services (CMS) as a Qualified Clinical Data Registry (QCDR). Participation in the registry supports regulatory initiatives such as the Merit-Based Incentive Payment System (MIPS) through the reporting of wound care-specific quality measures. These measures, developed and maintained by the USWR, are based on real-world care processes and outcomes derived from this registry. The USWR dataset may be linked to Medicare claims data through a secure tokenization process to support retrospective longitudinal analyses. This allows for the assessment of long-term patient outcomes including hospitalizations, readmissions, procedures, medication use, and mortality across care settings. The registry operates as part of a real-world evidence infrastructure and supports the principles of a learning healthcare system. By integrating quality reporting, research, and clinical care in a single data environment, the registry facilitates continuous learning and quality improvement at both the individual clinician and population levels.

Arms & Interventions

Arms

: chronic wound cohort

Patients with one or more chronic wounds or ulcers receiving standard of care at hospital-based outpatient wound centers. Interventions are recorded as part of routine care and include advanced dressings, compression bandaging, off-loading devices, cellular and/or tissue-based products, negative pressure wound therapy, hyperbaric oxygen therapy, topical oxygen therapy, MIST therapy, enzymatic debridement (e.g., collagenase), antimicrobial and collagen dressings, and bacterial imaging. All interventions are recorded by brand when applicable.

Interventions

Other: - Usual care

advanced dressings, off-loading, venous ulcer compression, arterial screening

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

US Wound Registry, The Woodlands, Texas

Status

Recruiting

Address

US Wound Registry

The Woodlands, Texas, 77386

Site Contact

Caroline E Fife, MD

[email protected]

800-603-7896