4. Information from trial registry.
| Title (comparator) | Current status | Relevant outcomes listed | Database | Results (# enrolled) | Listed contact | Company and any further information received |
| Phase IIa Randomised, Placebo Controlled Trial to Investigate Antimicrobial Photodynamic Therapy in Chronic Leg Ulcers and Diabetic Foot Ulcers (placebo = “cream”) | Prematurely ended (date unclear) | Photodynamic therapy using the combined effect of 3,7‐bis(N,N‐dibutylamino) phenothiazin‐5‐ium bromide (PPA904) and light; measure reduction of bacterial content of diabetic foot ulcers | ClincialTrialsRegister.eu EudraCT number: 2005‐001363‐58 |
None (not listed) | None listed. | Photopharmacia |
| Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (OneStep‐1 and 2) | Completed (August 2016) | 1°: clinical response (resolution of infection); 2°: microbiological response; safety |
ClinicalTrials.gov; NCT01594762 | No results (200 for each of the 2 trials) reported on website. | Robert Deluccia, Dipexium | Dipexium Pharmaceuticals, Inc. Multicentre study; all sites outpatient centre in USA |
| Comparison of Resin Salve and Octenidine in Patients with Neuropathic Diabetic Foot Ulcers (comparator: octenidine dihydrochloride‐impregnated gauze) | Completed (May 2015) | Investigate healing rate and healing time of neuropathic diabetic foot ulcer in people suffering from infected fore‐ or mid‐foot ulceration. 2°: eradication of bacteria; wound healing and infection | ClinicalTrials.gov; NCT02169167 |
No results on website (n = 35) (see addendum in “comments”) |
Janne J Jokinen | Salve prepared from Norway spruce (Repolar Ltd.) |
| Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver (investigator choice of silver) | Running until January 2017 (last updated November 2016) | Randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer. 1°: mean change in ulcer area at end of treatment; 2°: target ulcer infection rate | ClinicalTrials.gov; NCT02581488 | No results (102) | Jaime E Dickerson, PhD (Smith & Nephew) | (Smith & Nephew) Information from the sponsor received end of December 2016 stated that the trial is not yet complete but last participant out will be achieved in the next week. The trial enrolled its target number of participants, with the last participant completed December 2016. The evaluability will be carried out prior to the scheduled database lock in January 2017. As intention‐to‐treat is the analysis set for primary inference, it is anticipated that all participants will be included. Final study report is timed for April 2017 (15 December 2016). Waiting for further information to assess eligibility for review |
| Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin‐Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection | Recruiting (as of September 2013) | 1°: "clinical cure" at the test of cure; 2°: clinical response; time to clinical cure; eradication of baseline pathogen | ClinicalTrials.gov; NCT01951768 | No results (estimate 144) | Ilker Uckay, MD; Hospital of the University of Geneva | Innocoll, Inc. |
| Comparison of the Efficacy of Standard Treatment Associated with Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus aureus: a Randomized, Multi‐centre, Controlled, 2‐parallel‐group, Double‐blind, Superiority Trial | Starting January 2017 | 1°: reduction in wound surface area; 2°: safety; changes in resistance and virulence of S aureus isolates; production of anti‐phage antibodies |
ClinicalTrials.gov; NCT026647401 | No results (estimate 60) | Albert Sotto, MD, PhD +33.(0)6.09.56.66.55 |
Centre Hospitalier Universitaire de Nīmes; Pherecydes Pharma. Per correspondence from Prof Sotto on 8 January 2017, National Agency for the Safety of Medicines and Health Products requested “pre‐clinical phase complements”, causing a postponement of the start of the clinical trial. |
| A Phase I/IIa, Randomized Double Blind, Placebo‐Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu‐3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus (placebo) | Enrolling by invitation only (last verified April 2016) | Diabetic foot ulcers; infection localised to area of ulcer and mild. 1° outcome: treatment‐related adverse events, safety 2°: microbiological activity evaluated by wound assessments, presence of pathogenic bacteria |
ClinicalTrials.gov; NCT02737722 | No results (estimate 30) | Paul DiTullio, MSc | Lakewood‐Amedex, Inc. |
| A Phase II, Randomized, Parallel, Double‐blind, Placebo‐controlled Study to Assess Prevention of Infection Using a Topical Gentamicin‐Collagen Sponge in Diabetic Patients With Uninfected Lower Extremity Skin Ulcers (placebo sponge) | Terminated (last verified March 2012) | 1° outcome: uninfected diabetic foot ulcers that remain free of signs/symptoms of infection to end of study 2°: days to wound closure; time to any signs/symptoms of infection; decrease in wound area; pathogen burden in infected wounds |
ClinicalTrials.gov; NCT00658957 | No results (49) | David Prior, PhD; Chesapeake Foot and Ankle Center, Pasadena (MD), USA | Innocoll Pharmaceuticals |
| A Phase 3 Randomized, Placebo‐Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin‐Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With an Infected Foot Ulcer (COACT 1 and 2) (placebo is no sponge) | Last updated June 2016 | Sponge is adjunctive treatment to systemic antibiotic therapy. 1° outcome: per cent of participants with a clinical outcome of clinical cure (resolution of all clinical signs and symptoms of infection) ˜10 days after end of treatment; 2° outcomes: baseline pathogen eradication; re‐infection; time to clinical cure; amputation; ulcer closure |
ClinicalTrials.gov: NCT02447172 |
No results posted. | Nigel Jones, VP, Global Clinical Operations, Innocoll Pharmaceuticals | Innocoll Pharmaceuticals |
| Study of the Efficacy of Topical Application of Royal Jelly and Panthenol (PedyPhar® Ointment) on the Diabetic Foot Ulcers, an Open Label, Randomized, Non‐placebo‐controlled Study (active comparator panthenol ointment) | Terminated; (last updated February 2015) | Diabetic foot ulcers at any stage after proper surgical treatment (if needed) 1° outcome: healing of ulcer; 2°: reduction of infection in ulcer site; local reaction possibly related to study drug |
ClinicalTrials.gov; NCT01531517 | No results (estimate 120; 47 enrolled) | (?) | European Egyptian Pharmaceutical Industries |
| Platelet Rich Fibrin in Combination With Topical Antibiotics or Antiseptics in the Treatment of Chronic Wounds ‐ a Prospective, Randomized, Active Controlled, Double Blind Pilot Trial With an Observer‐blinded Control Group (3 platelet rich fibrin arms & 1 active comparator (Acticoat)) | Recruiting (last verified January 2016) | People with infected chronic wounds (unclear if diabetic foot) 1° outcome: reduction of wound area; 2°: number requiring systemic antimicrobial therapy; C‐reactive protein level; wound volume; occurrence of drug‐resistant bacteria |
ClinicalTrials.gov; NCT02652169 | No results (estimate 120) | Florian Thalhammer, Medical University of Vienna; 0043140400 ext 44400; florian.thalhammer@meduniwien.ac.at | Medical University of Vienna |
| Double Blind, Randomized, Placebo Controlled Clinical Trial for the Treatment of Diabetic Foot Ulcers, Using a Nitric Oxide Releasing Patch: PATHON | Completed (last verified November 2012) | 1° outcome: per cent reduction in ulcer size; 2°: complete cure of any infection; development of infection during treatment; adverse events |
ClinicalTrials.gov; NCT00428727 | No results (?) | Fundación Cardiovascular de Colombia | (?) |
| A Phase I/II, Open Label, Controlled Study to Evaluate the Safety and Efficacy of AppliGel‐G (Gentamicin Sulfate Topical Gel) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers in Patients With Type 1 and Type 2 Diabetes (comparator oral ciprofloxacin and doxycycline alone) | Terminated (last verified May 2015) | For mild to moderately infected diabetic foot ulcers 1°: complete wound clearing of infection 2°: incidence infection cleared; wound volume and area change |
ClinicalTrials.gov; NCT02036528 | No results | Royer Biomedical, Inc. | Royer Biomedical, Inc. |
| A Randomised, Double‐blind, Dose‐response, Placebo‐controlled, Multicenter, Phase IIA Clinical Study to Evaluate the Efficacy and Safety of Topical Application of G.68.y/EtOH in Patients with Type 1 or Type 2 Diabetes With Infected Foot Ulcers (placebo topical gel) | Completed | Enrolling patients with infected “grade 2 PEDIS” diabetic foot ulcers 1°: reduction of bacterial load 2°: maintenance of efficacy; tolerability and safety |
EudraCT number: 2010‐019598‐13 | No results (plan for 60) | I.CORTI@MOLTENIFARMA.IT | Molteni |
| Trial to Assess Safety and Efficacy of Topical MBN‐101 (BisEDT ) in Patients With Moderate/ Severe Diabetic Foot Infections (placebo – vehicle‐controlled) | Not yet open for participant recruitment (last update March 2016) | Part I, participants will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (active to placebo). In Part II, participants will be randomised in a 1:1 ratio (active to placebo) based on the optimal dose demonstrated in Part I. People with infected foot ulcer | ClinicalTrials.gov; NCT02723539 | No results (plan for 88) | Department of Vascular Surgery, Rigshospitalet Copenhagen, Denmark, 2100 |
Microbion Corporation |
Abbreviations: PEDIS, perfusion, extent/size, depth/tissue loss, infection, and sensation