An observational study in Diabetic Foot, Pressure Ulcer and Surgical Wound Dehiscence, sponsored by U.S. Wound Registry. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by U.S. Wound Registry · Observational
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.
WOUNDJOURNEY is a longitudinal, real-world observational registry focused on the chronic disease burden and patient journey of individuals with chronic wounds and ulcers. Data collection began in 2005 and continues prospectively, capturing structured clinical data at the point of care using a purpose-built certified EHR or EDC system. These data are securely transmitted to the U.S. Wound Registry (USWR), a CMS-designated Qualified Clinical Data Registry (QCDR).
All major wound types are represented: Diabetic foot ulcers (DFUs), diabetic ulcers not on the foot, Venous leg ulcers (VLUs), Arterial ulcers, Pressure ulcers/injuries, Surgical complications, Traumatic wounds, Vasculitic/inflammatory, and sickle cell-related ulcers, and chronic non-pressure ulcers.
The registry collects detailed data on standard-of-care practices and advanced wound care interventions, including brand-specific information on: Advanced dressings (e.g., collagen, antimicrobial), Compression therapy, Offloading devices, Cellular and/or tissue-based products (CTPs) also called Cellular, Acellular, or Matrix-like Products (CAMPs) or "skin substitutes," Negative pressure wound therapy, MIST therapy (low-frequency ultrasound), Topical oxygen therapy (TOT), Hyperbaric Oxygen Therapy (HBOT), Topical growth factors (e.g., Becaplermin), Enzymatic and mechanical debridement, Fluorescent imaging for bacterial load, Topical antibiotics and antimicrobials, and other treatments.
The registry captures key elements of the patient journey, including: Frequency of debridement, Sites of care, number of patient visits and number of wound visits, Dressing changes, Use and timing of advanced therapies, Comorbid disease burden and clinical complexity, Patient Frailty, number of wounds and ulcers per patient, patient time in service, wound time service, patient and wound outcomes, the development of new wounds while in service and complication rates.
Wounds are risk stratified using the Wound Healing Index, enabling case-mix adjustment and longitudinal outcome tracking. Follow-up may extend over five years, capturing outcomes such as: Complete healing (epithelialization), Non-healing, Major and minor amputations, Mortality, and Loss to follow-up or transfer of care. Quality of care is assessed using wound-specific quality measures. The registry integrates real-world clinical care with research and quality improvement, supporting a learning healthcare system model.
Through secure tokenization, registry data may be linked to payer claims for comprehensive longitudinal analysis of healthcare utilization, interventions, hospitalizations, medication use, and long-term outcomes across care settings. This enables rigorous, policy-relevant evaluations of standard care and advanced wound therapies in routine practice. The robust patient and wound level data are suitable to understand the natural history of chronic wounds and ulcers and to create historical controls for prospective clinical trials.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 300,000 is above the median of 100 across 191 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →U.S. Wound Registry is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic wounds or ulcers treated at participating sites in any US State and Puerto Rico. All patients and wounds are included without sampling. Each wound can be analyzed independently, even when multiple wounds exist on a single patient.
Sampling Method:
Non-Probability Sample
Minimum Age:
0 Years
Maximum Age:
None (patients aged 90+ are reported in aggregate per HIPAA)
Sex:
All
Gender Based:
No
Accepts Healthy Volunteers:
No
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)
This cohort includes pediatric and adult patients with one or more chronic wounds or ulcers treated in any site of care including hospital outpatient clinics, office-based practices, skilled nursing, and home. Data are captured prospectively during routine care using a purpose built certified EHR. Wounds include diabetic foot ulcers, venous leg ulcers, pressure ulcers/injuries, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Interventions are at the discretion of the treating clinician and include standard and advanced wound therapies. Data collected include patient demographics, comorbid conditions, medications, total number of concomitant wounds per patient, wound characteristics, treatments, visit frequency, complications, and outcomes including healing, amputation, recurrence, hospitalization, and death. Patients may be followed for over five years.
Other: Usual care
advanced dressings, off-loading, venous ulcer compression, arterial screening
Also known as: usual and customary care
Healed
Wound closure by secondary intention
Time frame: 1 year
Major amputation
Below the knee, above the knee
Time frame: 1 year
Minor amputation
toe amputation, transmetatarsal amputation, midfoot amputation
Time frame: 1 year
Patient Death
patient death while in treatment
Time frame: 1 year
Percent surface area (PAR) reduction over time
Percent surface area reduction (PSAR) is defined as the percentage decrease in wound surface area from the initial documented size at baseline (first qualifying wound care visit) to subsequent visits over time. Wound surface area is measured using length × width, captured at the point of care using structured fields within the electronic health record (EHR) or electronic data capture (EDC) system. Values are recorded in cm² and used to calculate PSAR as: \[(Baseline area - Follow-up area) ÷ Baseline area\] × 100 This metric is assessed at multiple time intervals, including 4 weeks, 12 weeks, 16 weeks, 6 months, and 12 months. PSAR is a key performance indicator for healing trajectory and is used to evaluate response to interventions. All wound types are included, and multiple wounds per patient are analyzed independently. Surface area measurements are case-mix adjusted using the Wound Healing Index for comparative effectiveness and quality reporting.
Time frame: variable - measured at multiple intervals (e.g., 4, 12, 16, 24, and 52 weeks)
Plan to share: Yes — De-identified individual participant data (IPD) collected through the U.S. Wound Registry (USWR) may be made available to qualified researchers, payers, regulatory agencies, or industry partners upon request. Shared data may include demographics, comorbidities, wound characteristics, interventions, and outcomes captured longitudinally in a structured electronic health record (EHR) or data capture system. All shared data comply with HIPAA de-identification standards and may be subject to data use agreements and institutional review board (IRB) approval.
Time frame: Available upon request after data quality review and registry updates are complete. IPD is available on an ongoing basis, with no fixed end date.
Access criteria: Access to de-identified individual participant data (IPD) may be granted to qualified researchers, payers, regulatory agencies, or industry partners upon request. Requests must include a research protocol or data use justification. Data access is contingent on execution of a data use agreement (DUA) and, where applicable, institutional review board (IRB) approval. All shared data will comply with HIPAA de-identification standards (45 CFR §164.514). The U.S. Wound Registry reserves the right to review all requests for scientific merit, relevance, and feasibility. Contact the registry to initiate a data access request. For access inquiries, contact: cfife@intellicure.com
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U.S. Wound Registry