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. 2014 Dec 8;2014(12):CD008394. doi: 10.1002/14651858.CD008394.pub3

Wethers 1994.

Methods Design trial: parallel (2 groups).
 Multicenter study: yes
 Study phase: no described.
 Follow‐up period: 10 weeks.
 Baseline observation period: none declared.
 Randomisation unit: patients.
 Unit of analysis: patients.
 Intention‐to‐treat analysis: yes.
Participants Randomised: 55 (RGD peptide matrix: 32) / placebo (23).
 Hb genotype: HbSS (50), HbSP thalassaemia (2), HbSC(1), HbSC Harlem (1), HbSD (1).
Completed study: 48 (87%). RDG peptide matrix (27/32 = 84%), placebo (21/23 = 91%)
 Loss: 7 (RGD peptide matrix: 5/32:16% ) / placebo (2/23:9%).
 Imbalance between both groups: 7%
 
 Age: median(± SE) and range: RGD peptide matrix: 32.9(1.8) years, range 18 ‐ 65 years; placebo: 36.6(2.3) years, range 26 ‐ 65 years.
Baseline ulcer duration (months) median(± SE) and range: RGD peptide matrix: 52.0 months (12.6), range 1 ‐ 312; placebo: 45.9 months (12.4), range 1 ‐ 192).
 
 Baseline ulcer area (cm2) median(±SE) and range: RGD peptide matrix: 14.8(3.3), range 0.4 ‐91.3; placebo: 11.0(2.4), range 0.9‐36.7.
Gender (male: female): RGD peptide matrix: 21:11; placebo: 12:11.
Inclusion criteria:

  1. isolated full‐thickness lower leg or ankle ulcers that did not involve bone or tendon and had persisted at least 1 month;

  2. age: ≥18 years old;

  3. informed written consent.


Exclusion criteria:

  1. medical conditions that might retard healing (immune system, diseases, uncontrolled diabetes, bleeding disorders, neurological disorders, or cancer requiring chemotherapy or radiation treatment);

  2. receiving medications that might adversely affect healing (systemic corticosteroids or antineoplastic agents);

  3. history of chronic transfusion therapy within the 3 months preceding study commencement.
Interventions RGD peptide matrix (Argidene gel: formerly Telio‐Derm gel, Telios Pharmaceuticals, Inc, San Diego, CA).
 Applications and dressing changes: once per week by 10 weeks.
Placebo: saline solution.
 Applications and dressing changes: once per week by 10 weeks.
Co‐intervention: debridament and cleaning at each visit.
Outcomes Primary: changes in per cent ulcer closure.
 Secondary: none declared.
Notes Country: conducted at USA.
 Sample size estimation a priori: no.
 Support: Telios Pharmaceuticals, Inc.
 Founder role: none declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote "sequentially assigned to treatment groups based on a unique randomization number list" (page 1776).
Comments: imbalance exists on 'baseline ulcer area (cm2 ).
 No Information reported about how "unique randomization number list" was generated.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement of ‘low risk’ or ‘high risk’.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patient and outcome assessor were blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Patient and outcome assessor were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Dropouts < 20%
Selective reporting (reporting bias) Low risk ‐
Other bias High risk Design bias (Appendix 2).

bd: twice a day
 SD: standard deviation
 SE: standard error