WeTreatFeet Podiatry: Pioneering Diabetic Foot Ulcer Clinical Trials in Maryland with Groundbreaking Skin Substitute Therapy

At WeTreatFeet Podiatry, a leading podiatry practice serving Maryland, Pennsylvania, and Washington DC, we are proud to announce our role as the only clinical trial site in Maryland for a revolutionary skin substitute product (XWRAP®) designed to accelerate healing in diabetic foot ulcers (DFUs). This randomized controlled trial represents a major advancement in regenerative medicine, offering new hope for patients struggling with chronic wounds. Below, we Tdetail the study’s significance, eligibility criteria, and why our practice stands at the forefront of this groundbreaking research.

This research is available only to patients in our Owings Mills, MD office!

About the Clinical Trial: XWRAP® Skin Substitute for Diabetic Foot Ulcers

This multicenter, FDA-regulated study evaluates the efficacy of XWRAP®, a single-layer amniotic membrane allograft derived from human placental tissue, combined with standard wound care or Standard of Care (SOC) versus SOC alone. As a Category 3 trial under CMS guidelines, this research aims to address the critical need for advanced therapies in diabetic wound management.

Key Study Details

Primary Objective: Compare complete wound closure rates at 12 weeks between XWRAP® + SOC and SOC alone.
Secondary Goals: Assess time to healing, reduction in adverse events (e.g., infections), and improvements in quality of life.
Sponsor: Applied Biologics™, a leader in regenerative medicine.
Study Design: Randomized, open-label trial with 124–150 participants nationwide.

XWRAP® acts as a protective barrier while delivering bioactive proteins to stimulate tissue regeneration. Processed in CLIA-certified labs meeting American Association of Tissue Banks (AATB) standards, this product has shown promise in prior studies for DFUs, venous leg ulcers, and pressure injuries.

Who Qualifies for This Study?

WeTreatFeet Podiatry is seeking participants who meet the following criteria:

Inclusion Criteria:

Adults aged 18+ with Type 1 or 2 diabetes.
Chronic diabetic foot ulcer (0.7–20 cm²) present for 4–52 weeks.
Ulcer located below the ankle (Wagner Grade 1 or 2).
Adequate blood flow to the affected limb (confirmed via ABI ≥0.7, TBI ≥0.6, or TCOM ≥40 mmHg).
Willingness to comply with weekly visits and offloading protocols.

Exclusion Criteria:

Active infection, osteomyelitis, or exposed bone/tendon in the ulcer.
HbA1c ≥12% or end-stage renal disease requiring dialysis.
Use of immunosuppressants, systemic steroids (>10 mg/day), or recent hyperbaric oxygen/CTP therapy.
Pregnancy or plans to become pregnant within 6 months.

Participants will undergo a 2-week screening period to confirm eligibility, followed by 12 weeks of treatment with close monitoring by our expert team1.

Why Choose WeTreatFeet Podiatry for This Trial?

As the exclusive Maryland site for this pioneering study, WeTreatFeet Podiatry brings unparalleled expertise to diabetic wound care and clinical research. Here’s why we stand out:

1. Leadership in Podiatric Research

Our founder, Dr. Mikel Daniels, is a board-certified podiatrist with over 20 years of experience in complex wound management. Our team contributes to peer-reviewed studies, cementing our reputation as innovators in limb preservation.

2. State-of-the-Art Technology

MolecuLight Imaging: Fluorescence imaging to detect bacterial burden and guide debridement.
Digital Planimetry: Precise wound measurements using AI-powered tools.
Advanced Offloading Systems: Defender® boots and total contact casts (TCC) to reduce pressure on ulcers.

3. Patient-Centered Care

Participants receive free weekly evaluations, cutting-edge dressings, and compensation ($50 per visit). Our holistic approach includes nutritional assessments, pain management (via PEG scale), and quality-of-life tracking to ensure optimal outcomes.

4. Ethical Excellence

This trial adheres to FDA 21 CFR 1271, HIPAA, and IRB guidelines. Safety monitoring includes 24/7 access to our medical team for adverse event reporting.

The Impact of XWRAP® on Diabetic Wound Care

Diabetic foot ulcers affect 15% of diabetics, with a 5-year mortality rate exceeding 42%-higher than many cancers. Standard therapies (debridement, offloading, moisture balance) often fail to close chronic wounds, leading to amputations and reduced quality of life. XWRAP® addresses these gaps by:

Preserving Structural Integrity: The amniotic membrane’s extracellular matrix supports cell migration and angiogenesis.
Reducing Bacterial Load: Early data show correlations between fluorescence imaging results and healing rates.
Minimizing Scarring: Epithelial regeneration promotes functional, cosmetically superior healing.

This trial aligns with CMS’s 2025 skin substitute coverage policies, which prioritize evidence-based CTPs for DFUs and venous ulcers

How to Participate:

Contact WeTreatFeet Podiatry: Call 410.363.4343 or fill the form below to schedule a screening.
Initial Evaluation: Our team will review your medical history, ulcer characteristics, and vascular health.
Randomization: Eligible participants are assigned to XWRAP® + SOC or SOC alone.
Weekly Visits: Track progress via imaging, blood tests, and pain/quality-of-life surveys.

WeTreatFeet Podiatry is redefining diabetic wound care through innovative research. By participating in this trial, you’ll access therapies years before they reach the market while contributing to a future where chronic ulcers are a preventable complication-not a life-altering diagnosis.

Join us in advancing medical science. Contact WeTreatFeet Podiatry today to learn more about eligibility and enrollment.

Keywords: diabetic foot ulcer clinical trial, skin substitute Maryland, XWRAP® study, CTP therapy, Wagner Grade ulcer treatment, regenerative podiatry, amniotic membrane allograft, WeTreatFeet research