Health TrialsbyHealthPanel

A Real-World Registry of Chronic Wounds and Ulcers

ConditionsDiabetic FootPressure UlcerSurgical Wound DehiscenceVasculitisSkin UlcerLeg UlcerPyodermaPeripheral Arterial DiseaseLymphedemaSurgical ComplicationVenous Leg Ulcers (VLUs)CalciphylaxisSickle Cell UlcerPressure Ulcer (PU)Diabetic Foot Ulcers (DFUs)Pressure InjuryArterial UlcersSoft Tissue Radionecrosis (STRN)Traumatic WoundsChronic Ulcer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorU.S. Wound Registry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of one or more chronic wounds or ulcers of any etiology

Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)

Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system

All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Usual care

    Other intervention

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

Treatment groups

300,000 Participants
are divided into 1 treatment group
Group A: chronic wound patients1 intervention

Trial outcomes

Primary outcomes

1

Healed

Wound closure by secondary intention

Time frame
1 year
2

Major amputation

Below the knee, above the knee

Time frame
1 year
3

Minor amputation

toe amputation, transmetatarsal amputation, midfoot amputation

Time frame
1 year
4

Patient Death

patient death while in treatment

Time frame
1 year

Secondary outcomes

1

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

U.S. Wound Registry

Lead sponsor

Source ClinicalTrials.gov
Apply now