Clinical trial • Phase III • Infectious Disease|Endocrinology
SODIUM HYPOCHLORITE for Diabetic foot ulcer
Phase III trial of SODIUM HYPOCHLORITE for Diabetic foot ulcer.
Overview
- Trial Therapeutic Area
- Infectious Disease|Endocrinology
- Trial Disease
- Diabetic foot ulcer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-10-2024
- First CTIS Authorization Date
- 05-11-2024
Trial design
Randomised, hocl (hypochlorous acid) topical treatment versus phmb (polyhexamethylene biguanide) topical treatment; doses and schedules not specified in available records.-controlled Phase III trial across 28 sites in Sweden.
- Randomised
- Yes
- Comparator
- HOCl (Hypochlorous Acid) topical treatment versus PHMB (Polyhexamethylene biguanide) topical treatment; doses and schedules not specified in available records.
- Target Sample Size
- 202
- Trial Duration For Participant
- 168
Eligibility
Recruits 202 Vulnerable population selected in trial metadata. Inclusion requires "Written and verbal informed consent given before trial-related activities". Participants must be adults (Age 18 years old or older). No explicit information provided on assent or consent by legally authorised representatives or languages of consent documents..
- Pregnancy Exclusion
- Current known pregnancy or planned pregnancy during the next 26 weeks by asking the participant.
- Vulnerable Population
- Vulnerable population selected in trial metadata. Inclusion requires "Written and verbal informed consent given before trial-related activities". Participants must be adults (Age 18 years old or older). No explicit information provided on assent or consent by legally authorised representatives or languages of consent documents.
Inclusion criteria
- {"criterion_text":"- Written and verbal informed consent given before trial-related activities"}
- {"criterion_text":"- Diabetes type 1, type 2 or diabetes due to pancreatitis"}
- {"criterion_text":"- Foot ulcer ≥ 10 days"}
- {"criterion_text":"- Ulcer surface area ≥ 9 mm2"}
- {"criterion_text":"- Age 18 years old or older"}
Exclusion criteria
- {"criterion_text":"- Persons in need of intensive care or dialysis."}
- {"criterion_text":"- Debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks."}
- {"criterion_text":"- Treatment with corticosteroids of a dose corresponding to 50 mg Prednisolone or higher."}
- {"criterion_text":"- Severe wound infection according to the International Working Group of the Diabetic Foot comprising at least 2 of the following signs: body temperature>38°C or <36°C, heart rate >90 beats/minute, respiration rate >20/minute, LPK>12 x 10^9"}
- {"criterion_text":"- Planned changed residence within the next 26 weeks requiring change of clinic for wound treatment during the follow-up time."}
- {"criterion_text":"- Age <18 years old."}
- {"criterion_text":"- If the toe or foot where the DFU is located likely needs amputation in close future or will undergo a spontaneous amputation or need judgement regarding this risk of amputation by further specialist (o.e. the DFU will not be possible to evaluate regarding healing effects)"}
- {"criterion_text":"- Diabetes of MOODY type."}
- {"criterion_text":"- Current known pregnancy or planned pregnancy during the next 26 weeks by asking the participant."}
- {"criterion_text":"- For participation in the sub study of 40 patients taking biopsies the DFU shall not be close to a joint, have direct skeletal contact or risk that such an appear and the DFU should not be ground with granular healing tissue."}
- {"criterion_text":"- Participation in another trial evaluating any treatment."}
- {"criterion_text":"- Other reasons judged by the investigator that the patient is unsuitable for participation in the study."}
- {"criterion_text":"- Persons in need of vascular intervention, critically impaired peripheral circulation (toe pressure < 30 mmHg)."}
- {"criterion_text":"- Current treatment of malignancy."}
- {"criterion_text":"- Event of myocardial infarction or stroke during the last 4 weeks."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint variable is difference in the time from baseline (randomization) to healing for patients randomized to treatment with HOCl and PHMB evaluated over 24 weeks of treatment measured as hazard ratio.","definition_or_measurement_approach":"Time from baseline (randomization) to complete healing evaluated over 24 weeks; comparison between HOCl and PHMB reported as a hazard ratio."}
Secondary endpoints
- {"endpoint_text":"- Proportion healed DFUs in HOCl group versus PHMB group at week 12.","definition_or_measurement_approach":"Proportion of diabetic foot ulcers healed at week 12 in each treatment arm; comparison between HOCl and PHMB."}
- {"endpoint_text":"- The difference in the change of the surface area of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) over 24 weeks.","definition_or_measurement_approach":"Change in ulcer surface area from baseline to up to 24 weeks; comparison between treatment arms."}
- {"endpoint_text":"- The difference in the change of the depth of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.","definition_or_measurement_approach":"Change in ulcer depth from baseline to week 24; comparison between treatment arms."}
- {"endpoint_text":"- Difference in the mean number of days of antibiotic treatment for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.","definition_or_measurement_approach":"Mean number of days on antibiotic treatment from baseline to week 24 compared between arms."}
- {"endpoint_text":"- Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.","definition_or_measurement_approach":"Change in EQ-5D quality-of-life scores from baseline to week 24; comparison between treatment arms."}
Recruitment
- Planned Sample Size
- 202
- Recruitment Window Months
- 60
- Consent Approach
- Written and verbal informed consent required from participants before trial-related activities ("Written and verbal informed consent given before trial-related activities"). Participants are adults (>=18). Subject information and informed consent form documents listed in CTIS (L1 documents). No details provided on assent, consent by legally authorised representatives, or languages available.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 202
Sweden
- Earliest CTIS Part Ii Submission Date
- 09-04-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 738
- Number Of Sites
- 28
- Number Of Participants
- 202
Sites
- Site Name
- Region Uppsala
- Department Name
- CTC, Dag hammarsköldsväg 10B, 75237 Uppsala
- Principal Investigator Name
- Jarl Hellman
- Principal Investigator Email
- jarl.hellman@akademiska.se
- Contact Person Name
- Jarl Hellman
- Contact Person Email
- jarl.hellman@akademiska.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Diabetesmottagning SUS Malmö, Tora Kjellgrens gata 17, Malmö
- Principal Investigator Name
- Eero Lindholm
- Principal Investigator Email
- eero.m.lindholm@skane.se
- Contact Person Name
- Eero Lindholm
- Contact Person Email
- eero.m.lindholm@skane.se
- Site Name
- Capio Legevisitten AB
- Department Name
- Capio Legevisitten Säbo, Karlsrovägen 1, 182 53 Danderyd
- Principal Investigator Name
- Mikaela Lundin
- Principal Investigator Email
- info@capio.se
- Contact Person Name
- Mikaela Lundin
- Contact Person Email
- info@capio.se
- Site Name
- Region Skane Aengelholms Sjukhus
- Department Name
- VO Medicin, Ängelholms sjukhus, Södra vägen 3, 28180 Ängelholm
- Principal Investigator Name
- Peter Kalén
- Principal Investigator Email
- peter.j.kalen@skane.se
- Contact Person Name
- Peter Kalén
- Contact Person Email
- peter.j.kalen@skane.se
- Site Name
- Familjeläkarna i Saltsjöbaden AB
- Department Name
- Familjeläkarna i Saltsjöbaden Vårdcentral, Byvägen 52, 13334 Saltsjöbaden, Region Stockholm
- Principal Investigator Name
- Olle Sjöstedt
- Principal Investigator Email
- kontaktamig@famlak.se
- Contact Person Name
- Olle Sjöstedt
- Contact Person Email
- kontaktamig@famlak.se
- Site Name
- Capio Närvård AB
- Department Name
- Capio Vårdcentral Simrishamn
- Principal Investigator Name
- Alexandra Nicolaidis Larsson
- Principal Investigator Email
- info@capio.se
- Contact Person Name
- Alexandra Nicolaidis Larsson
- Contact Person Email
- info@capio.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Endocrinology/Diabetes, Östra Sjukhuset, Diagnosvägen 11, 416 50 Göteborg
- Principal Investigator Name
- Sara Hallström
- Principal Investigator Email
- sara.el.nilsson@vgregion.se
- Contact Person Name
- Sara Hallström
- Contact Person Email
- sara.el.nilsson@vgregion.se
- Site Name
- Vaestra Goetalandsregionen
- Department Name
- Närhälsan Backa Vårdcentral, Rimmaregatan 2, 422 55 Hisings Backa
- Principal Investigator Name
- Karin Bergqvist
- Principal Investigator Email
- karin.bergqvist@vgregion.se
- Contact Person Name
- Karin Bergqvist
- Contact Person Email
- karin.bergqvist@vgregion.se
- Site Name
- Region Stockholm – SLSO
- Department Name
- Centrum för Diabetes, Solnavägen 1E, 113 65 Stockholm
- Principal Investigator Name
- Sergiu-Bogdan Catrina
- Principal Investigator Email
- sergiu-bogdan.catrina@ki.se
- Contact Person Name
- Sergiu-Bogdan Catrina
- Contact Person Email
- sergiu-bogdan.catrina@ki.se
- Site Name
- Sjukhusen I Vaester-Vaestra Goetalandsregionen
- Department Name
- Angered Hospital, Endocrinology/Diabetes, Halmtorget 1, 424 22 Angered
- Principal Investigator Name
- Marie Schönander
- Principal Investigator Email
- marie.m.schonander@vgregion.se
- Contact Person Name
- Marie Schönander
- Contact Person Email
- marie.m.schonander@vgregion.se
- Site Name
- NU Hospital Group-Vastra Gotalandsregionen
- Department Name
- NÄL, Clinical Trial Center, Endocrinology/Diabetes, Larketorpsvagen 20, 461 73 Trollhattan
- Principal Investigator Name
- Lennart Kareld
- Principal Investigator Email
- lennart.kareld@vgregion.se
- Contact Person Name
- Lennart Kareld
- Contact Person Email
- lennart.kareld@vgregion.se
- Site Name
- Vaestra Goetalandsregionen
- Department Name
- Närhälsan Ljungskile Vårdcentral, Vällebergsvägen 28, 459 30 Ljungskile
- Principal Investigator Name
- Tom Hagman
- Principal Investigator Email
- tom.hagman@vgregion.se
- Contact Person Name
- Tom Hagman
- Contact Person Email
- tom.hagman@vgregion.se
- Site Name
- Region Gaevleborg
- Department Name
- Diabetesmottagningen, Gävle sjukhus, Lasarettvägen 1, 80324, Gävle
- Principal Investigator Name
- Åke Sjöholm
- Principal Investigator Email
- kliniskaprovningar@regiongavleborg.se
- Contact Person Name
- Åke Sjöholm
- Contact Person Email
- kliniskaprovningar@regiongavleborg.se
- Site Name
- Region Vaesterbotten
- Department Name
- Backens Hälsocentral, Manusgränd 3, 901 24, Umeå
- Principal Investigator Name
- Olov Rolandsson
- Principal Investigator Email
- olov.rolandsson@umu.se
- Contact Person Name
- Olov Rolandsson
- Contact Person Email
- olov.rolandsson@umu.se
- Site Name
- Region Soermland
- Department Name
- Endocrinology/Diabetes, Olrogs Väg 1, Nyköpings lasarett, Nyköping
- Principal Investigator Name
- Vibeke Bergmark
- Principal Investigator Email
- vibeke.bergmark@regionsormland.se
- Contact Person Name
- Vibeke Bergmark
- Contact Person Email
- vibeke.bergmark@regionsormland.se
- Site Name
- NU Hospital Group-Vastra Gotalandsregionen
- Department Name
- Uddevalla hospital, Clinical Trial Center, Endocrinology/Diabetes, Fjällvägen 9, 451 53 Uddevalla
- Principal Investigator Name
- Lennart Kareld
- Principal Investigator Email
- lennart.kareld@vgregion.se
- Contact Person Name
- Lennart Kareld
- Contact Person Email
- lennart.kareld@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Skånes universitetssjukhus Lund, Endocrinology/Diabetes, Entrégatan 7, Lund
- Principal Investigator Name
- Erik Uddman
- Principal Investigator Email
- erik.uddman@skane.se
- Contact Person Name
- Erik Uddman
- Contact Person Email
- erik.uddman@skane.se
- Site Name
- Vaestra Goetalandsregionen
- Department Name
- Bergsjöns Vårdcentral, Rymdtorget 8D, 415 19 Göteborg
- Principal Investigator Name
- Malin Lagerberg
- Principal Investigator Email
- malin.lagerberg@notkarnan.se
- Contact Person Name
- Malin Lagerberg
- Contact Person Email
- malin.lagerberg@notkarnan.se
- Site Name
- Region Skane Kristianstad Central Hospital
- Department Name
- Medicinkliniken, Centralsjukhuset Kristianstad, J A Hedlunds väg 5, 29185, Kristianstad
- Principal Investigator Name
- Helene Holmer
- Principal Investigator Email
- Helene.I.Holmer@skane.se
- Contact Person Name
- Helene Holmer
- Contact Person Email
- Helene.I.Holmer@skane.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Endocrinology/Diabetes, Mölndals Sjukhus, Göteborgsvägen 31, 431 80 Mölndal
- Principal Investigator Name
- Emmy Cederqvist
- Principal Investigator Email
- emmy.cederqvist@vgregion.se
- Contact Person Name
- Emmy Cederqvist
- Contact Person Email
- emmy.cederqvist@vgregion.se
- Site Name
- Region Dalarna
- Department Name
- Endocrinology/diabetes, Lasarettsvägen 10, Falu Lasarett, Falun
- Principal Investigator Name
- Lars Hedlund
- Principal Investigator Email
- lars.b.hedlund@regiondalarna.se
- Contact Person Name
- Lars Hedlund
- Contact Person Email
- lars.b.hedlund@regiondalarna.se
- Site Name
- Vaestra Goetalandsregionen
- Department Name
- Capio Vårdcentral Strömstad
- Principal Investigator Name
- Mia Davidsson
- Principal Investigator Email
- mia.davidsson@capio.se
- Contact Person Name
- Mia Davidsson
- Contact Person Email
- mia.davidsson@capio.se
- Site Name
- Region Kronoberg
- Department Name
- Centrallasarettet Växjö, Strandvägen 8, 351 85 Växjö, Endocrinology/Diabetes
- Principal Investigator Name
- Karl Jägervall
- Principal Investigator Email
- karl.jagervall@kronoberg.se
- Contact Person Name
- Karl Jägervall
- Contact Person Email
- karl.jagervall@kronoberg.se
- Site Name
- Lasarettet I Motala Region Ostergotland
- Department Name
- Endocrinology/Diabetes
- Principal Investigator Name
- Ulf Rosenqvist
- Principal Investigator Email
- ulf.rosenqvist@regionostergotland.se
- Contact Person Name
- Ulf Rosenqvist
- Contact Person Email
- ulf.rosenqvist@regionostergotland.se
- Site Name
- Region Oerebro Laen
- Department Name
- Endokrinologi- och diabetesmottagningen, Örebro universitetssjukhus, Södra grevrosengatan, 70382
- Principal Investigator Name
- Christos Karefylakis
- Principal Investigator Email
- christos.karefylakis@regionorebrolan.se
- Contact Person Name
- Christos Karefylakis
- Contact Person Email
- christos.karefylakis@regionorebrolan.se
- Site Name
- Region Oestergoetland
- Department Name
- Endokrinmedicinska kliniken, Universitetssjukhuset Linköping, 581 85 Linköping
- Principal Investigator Name
- Simona Chisalita
- Principal Investigator Email
- Simona.Chisalita@regionostergotland.se
- Contact Person Name
- Simona Chisalita
- Contact Person Email
- Simona.Chisalita@regionostergotland.se
- Site Name
- Region Uppsala
- Department Name
- Östervåla Vårdcentral, Åbygränd 2, 740 46 Östervåla
- Principal Investigator Name
- Carina Eriksson
- Principal Investigator Email
- carina.ma.eriksson@akademiska.se
- Contact Person Name
- Carina Eriksson
- Contact Person Email
- carina.ma.eriksson@akademiska.se
- Site Name
- Vaestra Goetalandsregionen
- Department Name
- Närhälsan Tjörn Vårdcentral, Syster Ebbas väg 1, 47194 Kållekärr
- Principal Investigator Name
- Max Österlund
- Principal Investigator Email
- max.osterlund@vgregion.se
- Contact Person Name
- Max Österlund
- Contact Person Email
- max.osterlund@vgregion.se
Sponsor
Primary sponsor
- Full Name
- Vaestra Goetalandsregionen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Co-sponsors
- University Of Gothenburg
Investigational products
- Investigational Product Name
- SODIUM HYPOCHLORITE
- Active Substance
- SODIUM HYPOCHLORITE
- Modality
- Small molecule
- Routes Of Administration
- CUTANEOUS USE
- Route
- CUTANEOUS USE
- Maximum Dose
- Max daily dose 8 ml; max total dose 192 ml
- Investigational Product Name
- POLYHEXAMETHYLENE BIGUANIDE
- Active Substance
- POLYHEXAMETHYLENE BIGUANIDE
- Modality
- Small molecule
- Routes Of Administration
- CUTANEOUS USE
- Route
- CUTANEOUS USE
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