From real-world healing to
regulatory-grade documentation
DKD Phoxis builds evidence as a continuum: structured real-world data (RWD), pragmatic clinical protocols, and analytical characterization that supports a scalable phospholipid platform.
How DKD converts field outcomes into credible evidence
We separate “data” from “evidence”: RWD is collected consistently; RWE is generated via observational analyses and pragmatic/hybrid designs; clinical protocols are written to be scalable across sites without losing clinical reality.
RWD Registry (Operational)
What we capture — every case, in the same language.
- Inclusion/exclusion logic (minimal, practical) + comorbidity snapshot
- Wound type taxonomy (burn, chronic ulcer, necrosis, post-procedure, EB, etc.)
- Baseline severity rubric + pain/irritation scale + infection signs
- Standard photo protocol + follow-up schedule + dropout reasons
- Concomitant therapies + product exposure dose/frequency
- Adverse events + safety notes + escalation pathway
RWE Generation (Scientific)
How RWD becomes RWE — analyses and study designs.
- Observational cohorts with matched comparators (where feasible)
- Pragmatic/hybrid trials embedded in routine care settings
- Feasibility assessment: impact of inclusion/exclusion on eligible population
- Endpoints: time-to-closure, granulation, exudate control, pain, recurrence
- Subgroup analysis: comorbidity, age, chronicity, prior antibiotic exposure
- Protocol-to-publication pipeline: audit trail, version control, data dictionary
Clinical endpoints (core)
Designed for cross-site consistency and fast clinician adoption.
- Primary: healing status + time-to-heal (days)
- Secondary: granulation, epithelialization, odor, exudate, pain/irritation
- Safety: irritation, sensitization signals, unexpected reactions
Data integrity (grant-ready)
- Standard operating workflow + training checklist
- De-identified patient IDs + consent routing
- Photo timestamping + storage policy + audit log
Platform characterization (CMC-Lite)
For fund/grant review, we prioritize reproducibility: identity, purity, stability, and batch-to-batch consistency of the phospholipid platform.
Identity & composition
31P-NMR (class quant), total PL%, HPLC/UPLC profile, FA composition (GC).
Stability & impurities
Peroxide/Acid value, Karl Fischer water, residual solvents, metals (ICP-MS), micro limits.
Advanced fingerprint (optional)
Lipidomics MS for molecular species “signature” + differentiation vs references.
Dossier & evidence templates
Replace placeholder text with your current versions. These templates are structured to support grant submissions and fast scale to multi-site studies.
RWD Case Intake Form
Minimal inclusion/exclusion + baseline rubric + photo protocol + follow-up schedule.
RWD Registry Spreadsheet
Data dictionary + standardized fields for observational analysis and pragmatic trials.
CMC-Lite Dossier Outline
Identity, purity, stability, batch consistency + recommended analytical panel (Tier 1–3).
Turn your current cases into a standardized evidence pipeline
If you already have many real-world cases but documentation is inconsistent, we can convert it into a structured RWD registry (with audit trail) and a pragmatic protocol that supports grant review and future regulatory discussions.