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APPROVEDReviewed and approved by the Chamgap Editorial Team (2026-08-01). The draft was written by AI, the existence of all 1 cited sources was verified at the original page, and the verdict passed blind grading and adversarial audit. Methodology v0.6.
Verdict No. 1936 · Search date 2026-08-01 · Methodology v0.6

Injectable PDRN,
does it really help with Increased complete closure of chronic diabetic foot ulcers by eight weeks?

30-Second Summary
C
Evidence Grade C · 58 · Safety caution
Healing improved, but the evidence is one short manufacturer-supported trial without independent replication
Injection-site reactions and wound infection or ischemia require clinical monitoring. Patients with gangrene or untreated infection were excluded from the pivotal trial.
What the
research shows
The grade is C. A double-blind trial randomized 216 participants, 110 to PDRN and 106 to placebo, and 192 completed, 101/91. Intention-to-treat healing using randomized denominators was 41/110 (37.3%, 95% CI 28.2 to 46.3) versus 20/106 (18.9%, 11.4 to 26.3), P=0.0027, with healing HR 2.20 (95% CI 1.29 to 3.75). One manufacturer-supported confirmatory trial gives C with 58 points.
What the
ads claim
This was injectable PDRN added to standard wound care. The result cannot be transferred to oral products, cosmetics, joint injections, or every chronic wound merely because they share the PDRN name.
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Useful facts when choosing a product

  • The trial used a Mastelli Placentex-type formulation containing 5.625 mg PDRN per 3 mL, given intramuscularly five days per week and perilesionally two days per week for eight weeks.
  • Participants had selected Wagner grade 1 or 2 ulcers without gangrene or untreated infection and with transcutaneous oxygen pressure above 29 mmHg.
  • Verdict 588 is ? for oral PDRN and skin rejuvenation, while verdict 1907 is C with 45 points for knee injections; route and indication differ.
Gap Measurement · Verdict 1936 · C 58
What advertising claims
What independent, higher-quality research supports
△ GAP
01

What the research actually shows

Squadrito randomized 216 participants, 110 to PDRN and 106 to placebo, and 192 completed, 101/91. Healing percentages used randomized denominators in the intention-to-treat result: 37.3% versus 18.9%, HR 2.20 (95% CI 1.29 to 3.75), with median healing time 30 days for PDRN versus 49 for placebo. Mastelli supplied funding and product, and no large nonmanufacturer confirmatory trial of complete healing was identified. A small 2018 Korean trial assessed short-term tissue oxygenation and angiogenesis, not the same confirmatory endpoint. Verdict 1933 is B with 76 points for total contact casting in the same indication, where complete healing was replicated by two different small trials.

02

Why this is classified as C (58)

Complete closure improved by 18.4 points, but the manufacturer-supported evidence is a single short trial, giving C with 58 points.

Counterpoint. Independent long-term replication with recurrence and amputation outcomes is needed.

Rejudgment record. Cross-check applied — A double-blind 216-participant trial showed a large closure benefit, but it was a single eight-week manufacturer-supported confirmation without independent replication

Scoring profile behind this grade
EndpointHHard endpoint - actual events such as death
ReplicationR1Single confirmatory trial
IndependenceI0Evidence comes only from manufacturer studies
Effect sizeE+Meets the clinically important threshold

The scoring table and the verdict agree (C).

Sub-claim grades by effect

This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.

Effect (sub-claim)GradeBasis
Increased complete healing at eight weeksCRates were 37.3% versus 18.9%, but evidence comes from one product-linked trial.
Shorter time to healingCMedian time was 30 versus 49 days.

Cross-check — Codex and Claude

This verdict was drafted by Codex through literature review and source-existence checks, cross-checked through blind grading and adversarial audit, and settled by reapplying the methodology boundary rules. Cases with split grades were resolved through rejudgment.
03

Evidence Table

StudyDesignSampleFundingEndpointResultWeight
Study 1Two-center randomized double-blind placebo-controlled trial91Departmental funding plus Mastelli support and study-drug supplyComplete healing at eight weeks and time to healing41/110 (37.3%, 95% CI 28.2 to 46.3) versus 20/106 (18.9%, 11.4 to 26.3), P=0.0027; HR 2.20 (1.29 to 3.75); median 30 versus 49 daysOnly product-linked confirmatory trial
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Receipt — 1 References

All 1 cited sources were verified for existence at the original page (as of 2026-08-01).

Squadrito F, Bitto A, Altavilla D, et al. The effect of PDRN, an adenosine receptor A2A agonist, on the healing of chronic diabetic foot ulcers: results of a clinical trial. J Clin Endocrinol Metab. 2014;99(5):E746-E753. PMID: 24483158. DOI: 10.1210/jc.2013-3569.
checked
Draft and rewrite: Codex (AI) · Verification: Codex blind grading and adversarial audit · Final adjudication: Claude
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-08-01 · Corrections: none

Cite this verdict

Injectable PDRN x complete healing of diabetic foot ulcers Evidence Grade C card
[Chamgap] Injectable PDRN x complete healing of diabetic foot ulcers — Evidence Grade C·58. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/blood-sugar/injectable-pdrn-diabetic-foot-ulcer-complete-healing/ · CC BY 4.0

CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.

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