Short summary

Diabetic foot ulcers are among the most serious and economically demanding complications in diabetes. Several studies have found that the size and depth of the ulcer is one of the major etiologic factors for delayed healing. The aim of this study is to evaluate whether area and volumetric measurements of diabetic foot ulcers and venous leg ulcers are feasible in the assessment of ulcer healing and to evaluate the effect of treatment.

Rationale

The incidence of diabetic foot ulcers treated on the hospital comprises more than 3,000 per year in Denmark and in 2009 the prevalence was above 22,000. It is estimated that 85% of non-traumatic amputations are preceded by a diabetic foot ulcer. The most important etiological factors contributing to diabetic foot ulcers include neuropathy and arterial insufficiency. Furthermore, several studies have found that the size, including depth of the ulcer, is a major risk factor for delayed healing. A 3D photo-optical camera has been developed, which is able to measure the ulcer area and volume.

The purposes of the project are:

• To evaluate whether volumetric measurements of diabetic foot ulcers and venous leg ulcers are feasible in the assessment of ulcer healing.
• To evaluate the predictive power of percentage change in ulcer volume and area after 2, 4, 8, 12, 24, 36 and 52 weeks.
• To evaluate the impact on ulcer healing using different treatment strategies.
• To correlate clinical variables to healing of diabetic foot ulcers.

Perspectives:

This project seeks to clarify whether 3D photos of ulcers will provide accurate structural measures to illuminate the background for delayed ulcer healing, and thereby to create platform for a more evidence based treatment algorithm. The future vision is that a handheld 3D photo-optical camera can be used to evaluate the effect of different treatment strategies more accurately. This would help to qualify ulcer treatment, which is an area with no substantial evidence for specific treatments being more effective than others.

Description of the cohort

The cohort consists of newly admitted patients to University Centre for Wound Healing, Odense University Hospital with diabetic foot ulcer or venous leg ulcer.

Data and biological material

Patient history: Diabetic type, gender, age of diabetic debut, anti-diabetic treatment (insulin or tablet) BMI, diabetic complications (Retino-, nephro-, neuropati-, cardiovascular disease), hypertension, smoking habit.

Blood samples from patients at baseline: Hb, Na, K, creatinin, carbamid, HbA1c, urat

Measurement of the peripheral blood pressure at baseline. 

Ulcer examination including ulcer size (area and volume) at baseline and after 2, 4, 8, 12, 24, 36 and 52 weeks or until ulcer healing or amputation.

Survey SF-36v2 at baseline, and after 24 and 52 weeks.

Collaborating researchers and departments

Department of Medical Endocrinology, Odense University Hospital

• PhD-student Line Bisgaard Jørgensen
• Consultant and Associate Professor, Knud Yderstræde, MD, PhD

Department of Plastic Surgery, Odense University Hospital

• Professor Jens Ahm Sørensen, MD

Department of Dermatology, Roskilde Hospital

• Professor, Gregor Jemec, DMSc

Institute for Epidemiology, Biostatistics and Biodemography, the Faculty of Health Sciences, University of Southern Denmark

• Associate Professor Ulrich Halekoh