Nutritional Status in Adults With Diabetic Foot in an Outpatient Wound Clinic: A Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
This feasibility and pilot study has two aims. The primary aim is to assess the feasibility of collecting clinical, nutritional, and functional data among adults with diabetic foot ulcers (DFUs) who are treated at an outpatient wound clinic. Specifically, the study will evaluate recruitment and inclusion rates, the relevance and clinical utility of selected variables, and assess the completeness and reliability of data collection.
The secondary aim is to provide a preliminary characterisation of nutritional status, dietary intake, body composition, muscle strength, mobility, and wound-related quality of life, to inform the design and methodology of a future full-scale national study.
DFUs are associated with delayed healing, recurrent infections, reduced quality of life, and increased risk of hospitalization and amputation. These conditions are frequently accompanied by systemic inflammation, impaired circulation, and metabolic disturbances, which may increase nutritional requirements and negatively affect wound healing.
Despite nutrition being recognized as a modifiable factor of ulcer healing, the nutritional status of individuals with DFUs remains insufficiently characterised, and evidence regarding clinically relevant nutritional deficiencies in this population is limited.
Participants will undergo assessment of height, weight, body composition, handgrip strength, and a 24-hour dietary recall interview during an outpatient clinic visit. Nutritional screening questionnaires and patient-reported measures of appetite, nutritional impact symptoms, mobility, and quality of life will be collected through telephone interviews within one week of the clinical visit.
Eligible participants are adults (>18 years) who are referred to the outpatient wound clinic with a hard-to-heal foot ulcer. Participants must be able to communicate in Danish or English.
详细描述
Background Diabetic Foot Ulcers (DFUs) affect up to one third of individuals with diabetes and are associated with systemic inflammation, impaired circulation, and metabolic disturbances that may increase nutritional requirements and may impair collagen synthesis, immune function, and tissue repair in the foot ulcer. Despite nutrition being recognized as a modifiable factor in the ulcer healing process, the nutritional status of individuals with DFUs remains insufficiently characterized, and evidence regarding clinically relevant nutritional deficiencies in this population is limited. This feasibility and pilot study is designed to test the data collection procedure and generate preliminary descriptive data on nutritional status in a Danish outpatient population, in preparation for a future full-scale multicentre study.
Study Setting and Design Prospective observational feasibility and pilot study conducted at the Wound Outpatient Clinic, Department of Orthopaedic Surgery, Hvidovre Hospital, Denmark. Data are collected at two time points: a scheduled outpatient visit (Baseline) and a telephone interview within one week.
Recruitment Eligible patients are identified through the scheduled appointment list on designated inclusion days (Monday and Wednesdays). Wound care nurses review referrals in the electronic health record system prior to each clinic day and identify potentially eligible patients in collaboration with the research team. Upon arrival, patients are informed about the opportunity to participate in a research study and if patients express interest the researcher will provide oral and written information. Written informed consent is obtained prior to any data collection.
Data collected during the outpatient visit - Baseline:
- Anthropometry: (height, weight, BMI). If the participant is unable to stand upright, height is estimated from knee-to-heel length or fingertip-to-sternum distance (estimated 5 minutes)
- Body composition: bioelectrical impedance analysis (BIA) using the InBody S10, measuring muscle mass, fat percentage, and fluid balance. Performed between wound dressing removal and re-application. Omitted in participants with implanted electronic devices; mid-upper arm muscle circumference (MAMC) used as surrogate where BIA is not feasible (estimated 10 minutes)
- Muscle strength: Handgrip dynamometry, three maximal attempts with dominant hand, highest value recorded (estimated 10 minutes)
- Dietary intake: 24-hour dietary recall interview assessing all foods and beverages consumed in the preceding 24 hours. Portion sizes estimated using standardised photographic aids (Technical University of Denmark (DTU): National Dietary Survey) (estimated duration: 40 minutes). Macro- and micronutrient intake are calculated using www.Vitakost.dk
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosed with diabetes type 1 or type 2
- •Presence of one or more DFUs
- •Receiving treatment in a participating outpatient wound clinic
- •Able to provide written informed consent
排除标准
- •Above ankle amputation of the contralateral leg
- •Current treatment with intravenous antibiotics for acute infection.
- •Current hospitalisation for acute surgical management of the foot ulcer
- •Declining or unable to participate in a telephone follow-up interview.
- •Current long-term enteral (tube feeding) or parenteral nutritional support.
- •Exclusion criteria for bioelectrical impedance analysis (BIA)
- •- Presence of a cardiac pacemaker or other implanted electronic device
研究组 & 干预措施
Single cohort: Adults with type 1 or type 2 diabetes and one or more active DFUs
The cohort receive treatment at the Wound Outpatient Clinic, Hvidovre Hospital. No intervention is administered as part of this study.
干预措施: Protein supplementation and nutrition education (Behavioral)
研究者
Pia Søe Jensen
PHD, Associate Professor
Hvidovre University Hospital