Evidence map›Paper›PMID 23848141›Full record

Trial reportInternational wound journal2015

Treatment of chronic diabetic lower leg ulcers with activated protein C: a randomised placebo-controlled, double-blind pilot clinical trial.

Kaley Whitmont, Kelly J McKelvey, Gregory Fulcher, Ian Reid, Lyn March, Meilang Xue, Alan Cooper, Christopher J Jackson

Open access · bronzeAbstract readCase ReportsRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International wound journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.2field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 27 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Activated Protein C in Cutaneous Wound Healing: From Bench to Bedside.International journal of molecular sciences · 2019
    Review
  5. Review
  6. Targeting PAR1: Now What?Trends in pharmacological sciences · 2017
    Review
  7. Inflammation in Chronic Wounds.International journal of molecular sciences · 2016
    Review
  8. Activated protein C to heal pressure ulcers.International wound journal · 2016
    Article
  9. Review
  10. AMPK Activators as a Drug for Diabetes, Cancer and Cardiovascular Disease.Pharmaceutical regulatory affairs : open access · 2014
    Article
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Kaley WhitmontDepartment of Rheumatology, Sutton Arthritis Research Laboratory, Institute of Bone and Joint, Kolling Institute of Medical Research, University of Sydney at Royal North Shore Hospital, St Leonards, NSW, Australia.
Kelly J McKelveyDepartment of Rheumatology, Sutton Arthritis Research Laboratory, Institute of Bone and Joint, Kolling Institute of Medical Research, University of Sydney at Royal North Shore Hospital, St Leonards, NSW, Australia.
Gregory FulcherDepartment of Diabetes, Endocrinology and Metabolism, Royal North Shore Hospital, St Leonards, NSW, Australia.
Ian ReidDepartment of Rheumatology, Sutton Arthritis Research Laboratory, Institute of Bone and Joint, Kolling Institute of Medical Research, University of Sydney at Royal North Shore Hospital, St Leonards, NSW, Australia.
Lyn MarchDepartment of Rheumatology, Institute of Bone and Joint Research, University of Sydney, St Leonards, NSW, Australia.
Meilang XueDepartment of Rheumatology, Sutton Arthritis Research Laboratory, Institute of Bone and Joint, Kolling Institute of Medical Research, University of Sydney at Royal North Shore Hospital, St Leonards, NSW, Australia.
Alan CooperDepartment of Dermatology, Royal North Shore Hospital, St Leonards, NSW, Australia.
Christopher J JacksonDepartment of Rheumatology, Sutton Arthritis Research Laboratory, Institute of Bone and Joint, Kolling Institute of Medical Research, University of Sydney at Royal North Shore Hospital, St Leonards, NSW, Australia.
The University of Sydney · AURoyal North Shore Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lower leg ulcers are a serious and long-term complication in patients with diabetes and pose a major health concern because of the increasing number of patients diagnosed with diabetes each year. This study sought to evaluate the clinical benefit of topical activated protein C (APC) on chronic lower leg ulcers in patients with diabetes. Twelve patients were randomly assigned to receive either APC (N = 6) or physiological saline (placebo; N = 6) in a randomised, placebo-controlled, double-blind pilot clinical trial. Treatment was administered topically, twice weekly for 6 weeks with final follow-up at 20 weeks. Wound area was significantly reduced to 34·8 ± 16·4% of week 0 levels at 20 weeks in APC-treated wounds (p = 0·01). At 20 weeks, three APC-treated wounds had completely healed, compared to one saline-treated wound. Full-thickness wound edge skin biopsies showed reduced inflammatory cell infiltration and increased vascular proliferation following APC treatment. Patient stress scores were also significantly reduced following APC treatment (p < 0·05), demonstrating improved patient quality of life as assessed by the Cardiff Wound Impact Questionnaire. This pilot trial suggests that APC is a safe topical agent for healing chronic lower leg ulcers in patients with diabetes and provides supporting evidence for a larger clinical trial.

Indexed as

AgedAged, 80 and overChronic DiseaseDiabetic FootDouble-Blind MethodFemaleHumansLeg UlcerMaleMiddle AgedPilot ProjectsProtein CWound HealingProtein CActivated protein CDiabetesUlcerWound healing

Identifiers

PMID23848141
PMCPMC7950582
OpenAlexW2145852291

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.