Author (Year)

Country

Study Design

Sample Size

Intervention Details

Outcome Measures & Assessment Tools

Intervention

Control

Content

Duration

(Turan, et al. 2025) [14]

Turkey

RCT

34

34

Experimental group: The wound area was irrigated for 5-15 minutes with a solution that had been stored in a refrigerator for 24 hours, followed by wound dressing coverage.

Control group: The wound area was irrigated for 5-15 minutes with a warmed solution, followed by wound dressing coverage.

Not specified.

Pain (Visual Analogue scale)；Comfort level (Short General comfort Questionnaire)

(Thistlethwaite,et al. 2018) [15]

Australia

RCT

15

15

Experimental group: Following compression over 6 to 8 minutes, 100% oxygen was administered at 2.4 ATA (PiO₂ = 243.18 kPa) for two 40-minute sessions, with a 5-minute air break after the first session, followed by 30 minutes of decompression on 100% oxygen back to sea level. The total treatment time was 120 minutes per session.

Placebo group: The placebo group received air compressed to 1.2 ATA (PiO₂ = 25.53 kPa), followed by pressure cycling between 1.05 ATA and 1.2 ATA for 8 minutes before stabilizing at 1.05 ATA.

Treatments were administered 5 days per week for 6 weeks, or until ulcer healing occurred. The follow-up period was 6 weeks.

Pain; Quality of Life (SF-12v2)

(Ferreira, et al. 2023) [16]

Portugal

RCT

21

17,16

Relaxation Intervention Group: Progressive muscle relaxation with guided imagery.

Neutral Guided Imagery Placebo Group: Patient attention control involving imagining/recalling pre-diabetic foot ulcer daily life events.

Standard Drug Therapy Group: Received standardized DFU treatment from healthcare staff without relaxation/placebo interventions.

4 sessions over 2 weeks, 25 minutes/session.

Patient satisfaction; Quality of life (Diabetic Foot Ulcer Scale-Short Form; SF-36 Physical Component Summary; SF-36 Mental Component Summary); Perceived Stress (Perceived Stress Scale); Emotional Distress (Hospital Anxiety and Depression Scale).

(White, et al. 2015) [17]

UK

RCT

17

19

Experimental group: Non-contact low-frequency ultrasound therapy + standardized care.

Control group: Standardized care alone.

3 sessions per week, with each session lasting 3-112 minutes, for a total duration of 13 weeks.

Pain (Visual Analogue scale)；Quality of Life (Cardiff Wound Impact Schedule)

(Belhan, et al. 2025) [13]

Turkey

RCT

36

35

Experimental group: Wore virtual reality glasses during the wound care procedure.

Control group: Received routine care.

Not specified.

Pain (Numerical Pain Rating Scale); Anxiety (Spielberger State-Trait Anxiety Inventory).

(Kelechi, et al. 2022) [18]

USA

RCT

42,29

40,29

Experimental group: Application of a cooling patch to recently healed skin + standard care.

Placebo group: Application of a cotton-filled patch to recently healed skin + standard care.

Three times per week.

Depression (Geriatric Depression Scale); Pain (Brief Pain Inventory); Physical Activity (International Physical Activity Questionnaire).

(Pereira, et al. 2025) [19]

Portugal

RCT

21,15,17

16

Experimental group: Progressive muscle relaxation with guided imagery or hypnosis sessions plus usual care.

neutral sessions: Received neutral guided imagery sessions plus usual care.

Control group: Usual care only.

Sessions were conducted once every two weeks for 45 minutes per session over a 2-month period.

Quality of life (Diabetic Foot Ulcer Scale-Short Form; Short-Form Health Survey); illness perception (Brief Illness Perception Questionnaire); perceived stress (Perceived Stress Scale); anxiety and depression (Hospital Anxiety and Depression Scale).

(Galdino-Júnior, et al. 2024) [20]

Brazil

Randomized, single-blind, crossover trial

15

17

Sequence A/B: Treatment with heated saline (39.8 ± 0.6°C) followed by room-temperature saline (27.1 ± 1.1°C).

Sequence B/A: Treatment with room-temperature saline followed by heated saline.

Not specified

Pain (Numeric Rating Scale); Comfort level

(Liu & Shen, 2022) [21]

China

RCT

40

40

Experimental group: Chitosan-based hydrocolloid dressing.

Control group: Inert saline gauze dressing.

Dressings were changed every other day or daily depending on wound condition.

Pain (Visual Analogue scale)

(Shen & Shi, 2019) [11]

China

RCT

38

37

Experimental group: Application of virtual reality (VR) technology combined with advanced wound dressings.

Control group: Routine care.

Dressing change frequency was adjusted based on the wound stage.

Comfort level; Pain intensity (Visual Analogue scale)

(Liu, et al. 2025) [9]

China

RCT

50

50

Experimental group: Integrated continuing care (combined with routine continuing care).

Control group: Routine continuing care.

Not specified.

Pain (Numeric Rating Scale); Quality of Life (Generic Quality of Life Inventory); Patient Satisfaction.

(Tao, 2022) [12]

China

RCT

110

110

Experimental group: Moist Wound Healing Theory Care.

Control group: Routine Wound Care.

2 weeks.

Pain (Visual Analogue scale) ；Sleep quality (Pittsburgh Sleep Quality Index, PSQI); Quality of life (Brief Quality of Life Scale); Nursing satisfaction.

(Shen, et al. 2022) [10]

China

RCT

48

48

Experimental group: Internet-based collaborative care model + usual care.

Control group: Usual care.

Follow-up twice per month; wound care knowledge sharing once per week; health education lectures once per month; additional follow-ups based on wound condition (15-30 minutes per session).

Pain (Visual Analogue scale) ；Wound care knowledge and wound self-care ability; quality of life (Short-Form Health Survey).

(Jiang, et al. 2019) [8]

China

quasi-RCT

70

70

Experimental group: Multidisciplinary team (MDT) model.

Control group: Routine care.

Not specified.

Pain (Numeric Rating Scale); Self-efficacy (Self-Efficacy for Managing Chronic Disease Scale).