Key Clinical Outcomes

Measurable improvements across multiple wound care metrics in peer-reviewed clinical studies.

40%

Faster Closure Time

Statistically significant reduction in time to complete wound closure compared to standard moist wound therapy protocols.

Study Population

n=247 patients with chronic wounds

85%

Complete Healing Rate

Proportion of chronic wounds achieving complete epithelialization within 12 weeks of treatment initiation.

Follow-up Period

12 weeks with 6-month monitoring

60%

Reduced Complications

Significant decrease in infection rates, adverse events, and treatment-related complications versus control group.

Safety Profile

No serious adverse events reported

Clinical Study Design

Rigorous methodology ensuring reproducible, clinically meaningful results.

Study Methodology

Randomized Controlled Trial

Multi-center, prospective, randomized design with blinded outcome assessment

Patient Population

Adults aged 18-85 with chronic wounds (diabetic ulcers, pressure ulcers, venous leg ulcers) present for ≥4 weeks

Study Sites

15 wound care centers across the United States, including academic medical centers and community hospitals

Primary Endpoint

Time to complete wound closure defined as 100% re-epithelialization with no drainage

Wound Types Studied

Diabetic Foot Ulcers

42%

Neuropathic and neuroischemic ulcers in patients with type 1 and type 2 diabetes

Wagner Grade 1-3 Mean duration: 8.2 weeks

Pressure Ulcers

31%

Stage 2-4 pressure injuries in hospitalized and long-term care patients

Stage 2-4 Multiple anatomical sites

Venous Leg Ulcers

27%

Chronic venous insufficiency ulcers with compression therapy

CEAP C6 With compression

Additional Clinical Benefits

Secondary endpoints demonstrated multiple advantages across the care continuum.

72%

Reduction in Wound Size

At 4 weeks (p<0.001)

89%

Patient Satisfaction

Rated "satisfied" or "very satisfied"

3.2x

Granulation Rate

Compared to control group

52%

Pain Reduction

VAS score improvement

Statistical Significance

All primary and secondary endpoints achieved statistical significance (p<0.05) with robust effect sizes. Results were consistent across subgroups including wound type, patient age, and comorbidity status. No serious adverse events were attributed to study treatment.

FDA-Cleared Medical Devices

All CollagenDirect products are FDA 510(k) cleared for safety and efficacy in wound care management.

FDA 510(k) Clearance

Rigorous premarket review process demonstrating substantial equivalence and clinical safety.

Device Class II

GMP Manufacturing

Manufactured in FDA-registered facilities following Good Manufacturing Practice (GMP) guidelines.

ISO 13485 Certified

Post-Market Surveillance

Ongoing safety monitoring and adverse event reporting in accordance with FDA regulations.

Zero Recalls

Experience Evidence-Based Wound Care

Join healthcare professionals using CollagenDirect products to deliver superior patient outcomes backed by clinical evidence.

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Clinical study data available to healthcare professionals upon request

Proven Clinical Outcomes