Human study PLS-00031

Enhanced healing of ulcers in patients with diabetes by topical treatment with glycyl-l-histidyl-l-lysine copper.

Randomized controlled trial · Not reported participants enrolled

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • Enhanced healing of ulcers in patients with diabetes by topical treatment with glycyl-l-histidyl-l-lysine copper.primary · Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 1994-10-01 · PMID 17147644 · DOI

Design and participants

Design
Randomized controlled trial
Population
Patients with diabetes and neuropathic (plantar) foot ulcers. All received a standardized wound care protocol: sharp debridement at entry, pressure-relieving footwear and patient education.
Conditions
Diabetic neuropathic foot ulcer
Setting
Multicenter clinical study
Planned enrollment (registry)
Not reported
Enrolled
Not reported
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • GHK-Cu gel (Iamin Gel) (intervention) · ghk-cu · Glycyl-L-histidyl-L-lysine copper complex in a topical gel, applied daily as a metered dose alongside standardized wound care. · topical · Not reported assigned
  • Vehicle gel (comparator) · Vehicle gel alongside the same standardized wound care protocol. · placebo · topical · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Percentage area closure of plantar ulcers

unclear outcome · surrogate · Median percentage reduction in ulcer area

  • GHK-Cu gel (Iamin Gel) vs Vehicle gel: median 98.5 — Median area closure 98.5% with GHK-Cu gel vs 60.8% with vehicle, p<0.05
  • Vehicle gel: median 60.8 — Median area closure 60.8% with vehicle

Proportion of patients healing 98% or better

unclear outcome · patient-important · Proportion of patients with at least 98% ulcer closure

  • GHK-Cu gel (Iamin Gel) vs Vehicle gel: narrative — GHK-Cu gel significantly increased the proportion healing 98% or better

Rate of ulcer closure

unclear outcome · surrogate · Rate of wound closure

  • GHK-Cu gel (Iamin Gel) vs Vehicle gel: narrative — Closure rate described as three times faster than standard care and vehicle

Percentage area closure in larger plantar ulcers (>100 mm2 at entry)

unclear outcome · surrogate · Median percentage area closure in the subgroup with larger initial ulcer area

  • GHK-Cu gel (Iamin Gel) vs Vehicle gel: median 89.2 — Median closure 89.2% with GHK-Cu gel vs -10.3% with vehicle in larger ulcers, p<0.01
  • Vehicle gel: median -10.3 — Median closure -10.3% with vehicle in larger ulcers

Incidence of ulcer infection

unclear outcome · patient-important · Proportion of plantar ulcers that became infected, among ulcers treated immediately after debridement

  • GHK-Cu gel (Iamin Gel) vs Vehicle gel: proportion 7 — Infection incidence 7% with GHK-Cu gel vs 34% with vehicle, p<0.05
  • Vehicle gel: proportion 34 — Infection incidence 34% with vehicle

Adverse events

  • Ulcer infection · GHK-Cu gel (Iamin Gel): Not reported participants
  • Ulcer infection · Vehicle gel: Not reported participants

Monitoring: The study aimed to evaluate safety, but the abstract reports no adverse event monitoring methods or general adverse event data apart from ulcer infection incidence.

The authors concluded (paraphrased): Topical GHK-Cu gel added to standardized care improved closure of diabetic plantar ulcers versus vehicle, especially larger ulcers, and lowered infection rates. Treatment should start immediately after debridement.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • abstract only: Only the abstract is available, so sample size, randomization methods, dropouts and adverse event details cannot be assessed.
  • selective reporting: Key benefits are reported in subgroups (ulcers >100 mm2; ulcers treated immediately after debridement), suggesting possible post hoc analyses.
  • small or imprecise: No sample sizes, confidence intervals or exact p-values are reported; only thresholds such as p<0.05 are given.
  • other: General adverse events and tolerability are not reported despite the stated safety objective.
  • funding or conflicts: Funding and conflicts of interest are not stated. The product is a branded gel (lamin Gel), so industry involvement is possible.
  • inappropriate population: Only patients with diabetic neuropathic foot ulcers were studied. They differ from adults with photoaged skin.

Percentage area closure of plantar ulcers: Some concerns (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization processSome concernsDescribed as randomized, but sequence generation and allocation concealment are not reported in the abstract.
Deviations from intended interventionsSome concernsVehicle-controlled and evaluator-blinded, but participant blinding and adherence are not described; timing of treatment start varied.
Missing outcome dataSome concernsNumbers randomized, analyzed and lost to follow-up are not reported in the abstract.
Measurement of the outcomeSome concernsEvaluators were blinded, but the method of measuring wound area is not described.
Selection of the reported resultSome concernsNo protocol or prespecified analysis plan is available, and medians are given only with threshold p-values.

Some concerns in all domains because only an abstract with limited methodological detail is available.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Proportion of patients healing 98% or better: Some concerns (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization processSome concernsRandomization stated without details of sequence generation or concealment in the abstract.
Deviations from intended interventionsSome concernsParticipant blinding and adherence to daily application are not described in the abstract.
Missing outcome dataSome concernsAttrition and analysis populations are not reported anywhere in the abstract.
Measurement of the outcomeSome concernsEvaluator-blinded, but how 98% closure was determined is not described.
Selection of the reported resultSome concernsThe result is reported only narratively as significant, with no numbers, so selective reporting cannot be excluded.

Limited reporting in the abstract raises some concerns across all domains.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Rate of ulcer closure: Some concerns (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization processSome concernsRandomization stated, but methods are not reported in the abstract.
Deviations from intended interventionsSome concernsBlinding of participants and adherence are not described in the abstract.
Missing outcome dataSome concernsNo information on dropouts or completeness of outcome data.
Measurement of the outcomeSome concernsHow closure rate was calculated is not described, though evaluators were blinded.
Selection of the reported resultSome concernsReported only as 'three times faster' with no statistics, and the comparison mixes standard care and vehicle.

Narrative reporting without statistics and limited methods give some concerns.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Percentage area closure in larger plantar ulcers (>100 mm2 at entry): High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization processSome concernsRandomization not described, and balance within the size subgroup is unknown.
Deviations from intended interventionsSome concernsParticipant blinding and adherence are not described in the abstract.
Missing outcome dataSome concernsSubgroup sizes and attrition are not reported in the abstract.
Measurement of the outcomeSome concernsEvaluator-blinded, but the wound area measurement method is not described.
Selection of the reported resultHigh risk of biasThe size-based subgroup appears to be selected among possible analyses, with no evidence it was prespecified.

A likely post hoc subgroup result raises high risk of selective reporting.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Incidence of ulcer infection: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization processSome concernsRandomization stated without methods, and the subgroup was defined by timing of treatment start.
Deviations from intended interventionsSome concernsThe analysis is restricted to ulcers treated immediately after debridement, implying deviations in timing for others.
Missing outcome dataHigh risk of biasThe abstract does not report the denominators or any dropouts for the infection outcome.
Measurement of the outcomeSome concernsCriteria for diagnosing infection, and whether assessment was blinded, are not described.
Selection of the reported resultHigh risk of biasInfection data are reported only for the subgroup treated immediately after debridement, suggesting selective reporting.

Reporting restricted to a subgroup defined after randomization gives high risk of bias.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Claims this study informs

  • Very low certainty Adverse events, including skin reactions

Where each value comes from

  • adverse_events: PMID 17147644, abstract (sentence 7) · extracted by AI (automated, not verified by a person) · abstract only
  • arms: PMID 17147644, abstract (sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
  • author_conclusion: PMID 17147644, abstract (sentences 3-7) · extracted by AI (automated, not verified by a person) · abstract only
  • design: PMID 17147644, abstract (sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
  • limitations: PMID 17147644, abstract (sentences 5-7) · extracted by AI (automated, not verified by a person) · abstract only
  • outcomes: PMID 17147644, abstract (sentences 3-7) · extracted by AI (automated, not verified by a person) · abstract only
  • population: PMID 17147644, abstract (sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
  • results: PMID 17147644, abstract (sentences 3-5 and 7) · extracted by AI (automated, not verified by a person) · abstract only
  • Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).