Diabetes Clinical Trial
Official title:
Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers: a Parallel-group, Evaluator-blinded, Randomized Clinical Trial
This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel procedure developed by the research group. The definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response that will promote healing of the ulcers.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | INCLUSION CRITERIA - Age = 18 years - Diabetes mellitus - Non-surgical ulcer located distal to the malleoli - Wound diameter >4 millimeters - Patient-reported wound duration = 6 weeks Only one ulcer will be included from each participant. If a patient has more than one eligible ulcer, the largest ulcer is included. In case of equally sized ulcers, the ulcer with the most recent onset is included. EXCLUSION CRITERIA - Dementia or other reasons that cause inability to give informed consent - Malignant disease - Current treatment with systemic immunosuppressive drugs. Exclusion criteria related to the index extremity: - Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis - Non-palpable pulse in both arteria dorsalis pedis and arteria tibialis posterior accompanied by systolic toe pressure <30 mmHg in the index foot. - Amputation at midfoot level or proximal to midfoot level - Revascularization procedure awaits or has been undertaken within the last 8 weeks or the patient awaits a vascular surgeons' decision on revascularization - Gangrene Exclusion criteria related to the index ulcer - Infection of the ulcer defined according to IWGDF/IDSA (International Working Group on the Diabetic Foot/ Infectious Diseases Society of America system) classification as presence of at least 2 of the following; 1) local swelling or induration; 2) erythema >0.5 to =2 cm around the ulcer; 3) local tenderness or pain; 4) local warmth; or 5) purulent discharge. Current antibiotic treatment due to infection of the index ulcer will also be considered as an ongoing infection regardless of presence of clinical signs of infection. - Positive probe-to-bone test - Exposed joint or tendon - The soft tissue layer covering bone or joint is evaluated to be too thin to allow for inforatio technique anywhere in the wound bed. - Interdigital ulcer location |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev University Hospital, Department of Orthopaedic Surgery | Herlev | |
Denmark | Zealand University Hospital, Department of Orthopaedic Surgery | Køge | |
Denmark | Nykoebing Falster Hospital | Nykøbing Falster | |
Denmark | Slagelse Hospital, Department of Orthopaedic Surgery | Slagelse |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital | Steno Diabetes Center Sjaelland |
Denmark,
Andrews KL, Houdek MT, Kiemele LJ. Wound management of chronic diabetic foot ulcers: from the basics to regenerative medicine. Prosthet Orthot Int. 2015 Feb;39(1):29-39. doi: 10.1177/0309364614534296. — View Citation
Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/ — View Citation
Greer N, Foman NA, MacDonald R, Dorrian J, Fitzgerald P, Rutks I, Wilt TJ. Advanced wound care therapies for nonhealing diabetic, venous, and arterial ulcers: a systematic review. Ann Intern Med. 2013 Oct 15;159(8):532-42. doi: 10.7326/0003-4819-159-8-201310150-00006. — View Citation
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1. — View Citation
Karri VV, Kuppusamy G, Talluri SV, Yamjala K, Mannemala SS, Malayandi R. Current and emerging therapies in the management of diabetic foot ulcers. Curr Med Res Opin. 2016;32(3):519-42. doi: 10.1185/03007995.2015.1128888. Epub 2016 Jan 12. — View Citation
Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999 May;22(5):692-5. doi: 10.2337/diacare.22.5.692. — View Citation
Moeini S, Gottlieb H, Jorgensen TS, Larsen MRB, Brorson S. Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing: A Feasibility Trial. Int J Low Extrem Wounds. 2023 Jun;22(2):241-250. doi: 10.1177/15347346211002364. Epub 2021 Apr 28. — View Citation
Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273. — View Citation
Zimny S, Pfohl M. Healing times and prediction of wound healing in neuropathic diabetic foot ulcers: a prospective study. Exp Clin Endocrinol Diabetes. 2005 Feb;113(2):90-3. doi: 10.1055/s-2004-830537. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Inforatio related adverse events | Inforatio-related adverse events will be descriptively reported. Relatedness to inforatio technique will be qualitatively assessed as definitely related, probably related, probably not, or definitely not related. An event is assessed as probably not related to inforatio technique when the event is most likely to be explained by side effects from other treatments; a natural course of DFUs; or the clinical condition of the participant. | 20 weeks | |
Other | Ulcer-related adverse events | Following adverse events related to the index ulcer will be reported:
Total wound area increase during follow-up Infection of the ulcer Exposure of bone, tendon or joint in the wound bed Osteomyelitis of underlying bone is diagnosed Surgical wound intervention of the ulcer in an operating theater Hospitalization related to the ulcer Minor amputation of the index extremity (below ankle) Major amputation of the index extremity (above ankle) Mortality related to the ulcer The events will be descriptively reported and analyzed on 'as treated' basis where participants are grouped according to whether they received inforatio technique. Mean time and range from the last inforatio applied to an event is detected will be reported for the intervention group. A statistical comparison between groups will be conducted for proportion of participants experiencing one or more adverse events related to the index ulcer. |
20 weeks | |
Other | Patient-reported adverse events | Patient-reported adverse events related to index ulcers: Participants are asked at each follow-up visit whether they have experienced onset of an ulcer-related adverse events since their last trial visit.
Adverse events related to inforatio technique application: Participants from the intervention group are asked after each inforatio technique application whether they experience any adverse events during or immediately after application. |
20 weeks | |
Other | Serious adverse events | Serious adverse events are defined according to FDA (U.S. Food and Drug Administration) as death, life-threatening events, hospitalization, disability or permanent damage. The outcome will be descriptively reported and analyzed on 'as treated' basis where participants are grouped according to whether they received inforatio technique. A statistical comparison between groups will be conducted for proportion of serious adverse events. | 20 weeks | |
Other | One-year mortality | Events of death during the first year from baseline. | 1 year | |
Other | One-year amputation rate | Events of amputation in index extremities during the first year from baseline. | 1 year | |
Primary | Complete healing | Healing is defined as complete epithelialization without any discharge from the site of the index ulcer.
The primary outcome is the proportion of ulcers in each allocation group where healing is observed based on blinded assessment of digital images from the participants' last trial visit. The assessment of healing on digital images will be performed separately by two blinded assessors. Digital images where disagreement occurs are discussed between the assessors until agreement is reached. Any inconsistencies between the blinded assessment of healing on images and unblinded clinical assessment at trial visits will be reported. In case of death and amputation the primary outcome is registered as non-healing. |
20 weeks | |
Secondary | Change in EQ-5D-5L visual analog scale (EQ VAS) score from baseline to end of follow-up | The EQ VAS score is used to assess change in participant-rated health from baseline to end of follow-up.
Participants fill out the Danish version of the EQ-5D-5L questionnaire at baseline and the last trial visit or after 20 weeks from the day of amputation if participants undergo amputation of their index limb during follow-up. EQ-5D-5L is a general health patient-reported outcome measure that includes a visual analog scale and a descriptive 5-dimension system. Permission to use EQ5-5D-5L (registration ID 39403) has been obtained. In case of death, the EQ VAS score will be registered as missing. |
20 weeks | |
Secondary | Change in Wound-QoL global score from baseline to end of follow-up | Wound-QoL global score is used to assess change in disease-specific quality of life from baseline to end of follow-up.
Participants fill out the Danish version of the Wound-QoL questionnaire at baseline and the last trial visit. The Wound-QoL is a disease-specific patient-reported outcome measure that consists of 17 items, which each has a score from 0 to 4 - 0 indicates no problem and 4 is the highest score for an ulcer-related problem. The global Wound-QoL score is an average of all item scores. In case of death, the Wound-Qol score will be registered as missing. In case of amputation of the index extremity, the Wound-QoL global score is 4, which represents the worst possible outcome for Wound-QoL. The Wound-QoL response is defined as missing if less than 13 of the 17 items have been completed. Permission to the Danish version of the Wound-QoL has been obtained. |
20 weeks |
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